Implants and Instruments with Flexible Features

ABSTRACT

According to one embodiment of the disclosure, an implant includes a body having a surface with a flexible pattern defined by a plurality of material segments including a first material segment and a second material segment. The first material segment abuts the second material segment. Further, the first material segment includes a first non-linear shape extending between a first end and a second end while the second material segment includes a second non-linear shape extending between a first end and a second end. The two material segments are interconnected such that one of the first end and the second end of the first non-linear shape is interconnected with one of the first end and the second end of the second non-linear shape.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication Nos. 62/616,062 filed Jan. 11, 2018, 62/616,071 filed Jan.11, 2018, 62/616,073 filed Jan. 11, 2018, 62/616,076 filed Jan. 11,2018, and 62/616,078 filed Jan. 11, 2018, the disclosures of which areincorporated by reference herein in their entirety.

FIELD OF THE INVENTION

The invention relates generally to implants and instruments comprisingat least one surface with a flexible pattern, wherein the flexiblepattern includes a continuous line of material.

BACKGROUND OF THE INVENTION

Various implants and instruments are used in spinal surgery. Many ofthese include rigid surfaces that may be an impediment to optimal use ofsuch implants and instruments. Specific non-limiting illustrations ofchallenges associated with use of these elements are outlined below.

Flexible Interbody

After a partial or complete discectomy in which a damaged intervertebraldisc is removed, a normally occupied space between adjacent vertebralbodies is subject to collapse and/or misalignment due to the absence ofall or a part of the intervertebral disc. In such situations, aphysician may insert one or more prosthetic interbodies between theaffected vertebrae to maintain normal disc spacing and/or the normalamount of lordosis in the affected region. The normally occupied discspace is not a consistent size between vertebrae. Additionally, the discspace is different in different patients. For this reason, prostheticinterbodies are made of varying size and dimensions so that a physiciancan select an interbody that most closely matches the disc space.

However, current prosthetic interbodies include rigid surfaces that donot mimic the curvatures of the adjacent vertebral bodies. For thisreason, gaps are present between the vertebral body and the prostheticinterbody that may take an extended period of time before bone growthhas occurred. There exists a possibility that prosthetic interbodies maybe dislodged or moved from their desired implantation location due tomovement by the patient before sufficient bone growth has occurred.

Therefore, a need exists for prosthetic interbody that provides adesired amount of lordosis, allows for bone growth between adjacentvertebrae, maintains the space between adjacent vertebrae during boneingrowth, and resists dislocation from its implantation site.

Fixation Member

Spinal pathologies, whether the result of genetic or developmentalirregularities, trauma, chronic stress, tumors, or disease can limit thespine's range of motion or threaten critical elements of the nervoussystem housed within the spine. A variety of systems to correct thealignment of the spinal vertebrae involving the implantation ofartificial assemblies in or on the spine have been devised.

The mechanical hardware used to immobilize the spinal column typicallyinvolves a series of bone screws and metal rods or plates. When thespine surgery is performed posteriorly, it is common practice to placebone screws into the vertebral bodies and then connect a metal rodbetween the screws, thus creating a rigid structure between adjacentvertebral bodies. In some cases, the use of these devices may bepermanently implanted in the patient. In other cases, the devices may beimplanted only as a temporary means of stabilizing or fixing the bonesor bone fragments, with subsequent removal when no longer needed.

When using screws, the surgeon directs the screw into the vertebralbody. Because different patients have different anatomies, there existsthe potential that a screw may need to be implanted in a differentdirection than the final trajectory of the screw. For example, mostprocedures are done through very small incisions. Access into thevertebral body may be at a different angle than the angle at which thesurgeon wants the screw to be inserted. For example, if a screwdriver isinserted at an orientation perpendicular to the table/patient, the screwmay need to be inserted into the vertebral body at a 45° angle to thepatient. The small incision makes it difficult for the surgeon to anglethe screwdriver to 45° without increasing the size of the incision.

Additionally, the anatomy of the patient may interfere with a surgeon'sability to insert a screw. For example, when trying to insert a caudallyoriented screw into the neck at a high cervical level, i.e., C1-C3, thepatient's chin may prevent the surgeon from being able to angle thescrewdriver to match the desired insertion angle of the screw.

Therefore, a continuing need exists for an improved fixation member thatcould reduce the time and labor required by a user to insert thefixation member, such as a screw, into a vertebra, while also protectingthe spinal nerves and preventing redirection.

Flexible Instrument

There has been considerable development of retractors and retractorsystems that are adapted for use in less invasive procedures. Many ofthe recent developments are based on traditional types of surgicalretractors for open procedures, predominantly table-mounted devices ofvarious designs. These devices tend to be cumbersome and are not welladapted for use in small incisions. Standard hand-held surgicalretractors can be modified to fit the contours of these small incisions,but they require manual manipulation to maintain a desired placement,thereby occupying one hand of the physician or requiring another personto assist the physician during the procedure. Typical retractors arealso positioned into the soft tissue and are levered back to hold thewound open, frequently requiring re-positioning if they dislodge,obstruct the physician's view, or interfere with access to the surgicalsite.

In a spine fusion, at least two vertebral bodies are rigidly connectedusing screws implanted into the respective vertebral bodies with a solidmetal rod spanning the distance between the screws. The insertion ofpedicle or facet screws is relatively straightforward and can beaccomplished through a minimal incision. The difficulty arises upon theintroduction of a length of rod into a very small incision withextremely limited access and visibility. The minimal incision should bemaintained in an open and accessible condition (i.e. as wide aspracticable) for introduction of the rod.

In order to be truly minimally invasive, a spine fusion procedure shouldhave a minimum number of small incisions and not require significanttissue and/or muscle retraction. Furthermore, an improved approachshould encompass as many variations and applications as possible therebyallowing the surgeon to adjust the procedure to accommodate the anatomyand surgical needs of the patient as presented. For instance, spinalfusions should not be limited to just one or two levels.

What is needed is a device that works with current instruments toprovide the necessary, and possibly limited, retraction needed in aspinal procedure with an ease of use and without impairing a view of thesurgical field.

Flexible Rod

Spinal pathologies, whether the result of genetic or developmentalirregularities, trauma, chronic stress, tumors, or disease can limit thespine's range of motion or threaten critical elements of the nervoussystem housed within the spine. A variety of systems to correct thealignment of the spinal vertebrae involving the implantation ofartificial assemblies in or on the spine have been devised.

The mechanical hardware used to immobilize the spinal column typicallyinvolves a series of bone screws and metal rods or plates. When thespine surgery is performed posteriorly, it is common practice to placebone screws into the vertebral bodies and then connect a metal rodbetween the screws, thus creating a rigid structure between adjacentvertebral bodies. In some cases, the use of these devices may bepermanently implanted in the patient. In other cases, the devices may beimplanted only as a temporary means of stabilizing or fixing the bonesor bone fragments, with subsequent removal when no longer needed.

The process of properly inserting a rod into the receiving slot of abone anchor and then securing that connecting rod in place can oftenrequire that the surgeon use a number of instruments and expend a greatdeal of time and effort. When bone anchors in several adjacent vertebraeare to be securely connected by a spinal rod, the repeated process ofinserting the rod into the heads of the bone anchors and then securingthe rod in place for each respective bone anchor can be difficult,tiresome and time consuming. Further, the alignment of the rod as itconnects to each of the sequential bone anchors may require adjustmentduring the procedure and, therefore it is necessary that the rod can bereduced into the head of each of the sequentially aligned bone anchorsand, as necessary, easily adjusted so as to facilitate the process forthe surgeon with minimal effort and loss of time.

Additionally, there are sometimes clinical issues that arise in an areabetween an instrumented level with a non-flexible rod and anon-instrumented level. In particular, this area may experience higherstresses that may lead to future damage of the anatomy.

Corpectomy

The human spine includes thirty-three vertebrae. The vertebrae interlockwith one another to form a spinal column. Each vertebra has acylindrical bony body (vertebral body), two pedicles extending from thevertebral body, a lamina extending from the pedicles, two wing-likeprojections extending from the pedicles, a spinous process extendingfrom the lamina, a pars interarticularis, two superior facets extendingfrom the pedicles, and two inferior facets extending from the lamina.The vertebrae are separated and cushioned by thin pads of tough,resilient fiber known as intervertebral discs. Intervertebral discsprovide flexibility to the spine and act as shock absorbers duringactivity. A small opening (foramen) located between each vertebra allowspassage of nerves. When the vertebrae are properly aligned, the nervespass through without a problem. However, when the vertebrae aremisaligned or a constriction is formed in the spinal canal, the nervesget compressed and may cause back pain, leg pain, or other neurologicaldisorders.

Disorders of the spine that may cause misalignment of the vertebrae orconstriction of the spinal canal include spinal injuries, infections,tumor formation, herniation of the intervertebral discs (i.e., slippageor protrusion), arthritic disorders, and scoliosis. In these pathologiccircumstances, surgery may be tried to either decompress the neuralelements and/or fuse adjacent vertebral segments. Decompression mayinvolve laminectomy, discectomy, or corpectomy. Corpectomy involvesremoval of the vertebral body as well as the adjacent intervertebraldiscs.

One of the challenges during surgery is to rebuild a prostheticvertebral implant, in real time, that matches the curvature of the spineand the dimensions of the vertebral body.

Therefore, a need exists for devices to be used in spinal surgeries thatprovide a user, such as a surgeon, with the ability to quickly andaccurately design a corpectomy device with a curvature and dimensionsthat are approximate to the discarded vertebral body.

BRIEF SUMMARY OF THE INVENTION

In one aspect, there is disclosed an interbody including at least onesurface including a flexible pattern, wherein the flexible patternincludes a continuous line of material.

In some examples, the interbody has at least two surfaces each having anindependent flexible pattern. In other examples, the interbody has up tosix surfaces each having an independent flexible pattern. In stillfurther examples, the interbody is symmetric. In others, it isasymmetric. In some examples, the flexible pattern includes a pluralityof segments that interconnect to form rows and columns. In someexamples, each segment of the plurality of segments has a first end anda second end. The first end of each segment may interconnect with atleast one second end of another segment of the plurality of segments. Insome examples, a first end of each segment interconnects with threedifferent segments. In variants of these examples, a second end of eachsegment may interconnect with three different segments. In someexamples, the interbody has at least one non-flexible surface. In someexamples, the interbody may have at least one smooth surface. In yetanother example, the at least one flexible surface includes a smoothsurface. In some examples, the interbody has at least one surface with aplurality of projections and grooves.

In one aspect, there is disclosed a fixation member comprising a headand at least one surface including a flexible pattern. The flexiblepattern may include a continuous line of material.

In some examples, the flexible pattern includes a plurality of segmentsthat interconnect to form rows and columns. In other examples, eachsegment of the plurality of segments has a first end and a second end.The first end of each segment may interconnect with at least one secondend of another segment of the plurality of segments. A first end of eachsegment may interconnect with three different segments. Further, asecond end of each segment may interconnect with three differentsegments. In some examples, a distal end may include a non-flexiblesurface. In other examples, a body of the fixation member may include anexterior helical thread. In still further examples, the head may includean exterior helical thread. In some examples, the head may include akeyed inner surface. In some examples, the flexible pattern extends atleast quarter of a length of the fixation member. The flexible patternmay extend at least half of a length of the fixation member.

In another aspect, there is disclosed a method for inserting a fixationmember performed by inserting the fixation member into an insertion holeand applying a force to a head of the fixation member.

In one aspect, there is disclosed a flexible instrument including an armand an elongated portion including at least one surface with a flexiblepattern having a continuous line of material.

In some examples, the elongated portion is configured and dimensioned toretract tissue. The flexible pattern may include a plurality of segmentsthat interconnect to form rows and columns. In some examples, eachsegment of the plurality of segments has a first end and a second end.The first end of each segment may interconnect with at least one secondend of another segment of the plurality of segments. A first end of eachsegment may interconnect with three different segments. A second end ofeach segment may interconnect with three different segments. In someexamples, the flexible instrument also includes at least onenon-flexible surface.

In one aspect, there is disclosed a rod comprising a first end, a secondend, and a body with a flexible pattern having a continuous line ofmaterial.

In some examples, the flexible pattern includes a plurality of segmentsthat interconnect to form rows and columns. In other examples, eachsegment of the plurality of segments has a first end and a second end.The first end of each segment may interconnect with at least one secondend of another segment of the plurality of segments. A first end of eachsegment may interconnect with three different segments. And, a secondend of each segment may interconnect with three different segments. Insome examples, the flexible pattern extends at least quarter of a lengthof the rod. The flexible pattern may extend at least a half of a lengthof the rod. In some examples, the body includes a surface with aflexible pattern and a non-flexible surface.

In one aspect, there is disclosed an adjustable cage device thatincludes at least one surface with a flexible pattern having acontinuous line of material.

In some examples, the cage includes at least one endplate. The at leastone endplate may include a flexible pattern. Alternatively oradditionally, the endplate may include a channel configured anddimensioned to receive the at least one surface. In some examples, thecage includes an opening. A bone support matrix may be included withinthe opening. In some examples, the cage includes a housing. In otherexamples, the cage includes a support member. In further examples, thecage includes a top surface. Any one of the housing, support member ortop surface may include the flexible pattern.

In one aspect, the present disclosure relates to a flexible patterndefined by a plurality of segments including a first segment and asecond segment. The first segment includes a first non-linear shape thatextends between a first end and a second end and the second segmentincludes a second non-linear shape that extends between a first end anda second end. In this structure, one of the first end and the second endof the first non-linear shape is interconnected with one of the firstend and the second end of the second non-linear shape.

In some examples, the flexible surface may be included in an implant. Insome examples, the implant may be a fixation member. Where the implantis a fixation member, the fixation member may include an exteriorhelical thread. The fixation member may include a head with a keyedinner surface. The flexible pattern may extend at least half of a lengthof the fixation member. In further examples, the implant may be a rod.In some examples, the implant may be an adjustable cage device. Theadjustable cage device may include an endplate. In some of theseexamples, the endplate may include a flexible pattern. In otherexamples, the endplate may include a channel configured and dimensionedto receive the flexible surface. In some examples where the implant isan adjustable cage device, the adjustable cage device may include ahousing that has a flexible pattern. In others, the adjustable cagedevice may include a support member that includes a flexible pattern. Instill others, the adjustable cage device may include a top surface thatincludes a flexible pattern. In some examples, the implant may be aninterbody adapted for placement in a mammalian spine. In other examples,the flexible surface may be included in an instrument. The instrumentmay be a blade and the blade may be configured and dimensioned toretract tissue.

In some examples, the plurality of segments may include a third segmentthat abuts the first segment such that a first axis through a center ofthe first and second segments is orthogonal to a second axis through acenter of the first and third segments. In other examples, the pluralityof segments may interconnect to form rows and columns. In some examples,the plurality of segments may include a continuous line of material. Insome examples, the first non-linear shape may be the same as the secondnon-linear shape. In further examples, the flexible surface may alsoinclude a second flexible surface with a second flexible patterndifferent from the first flexible pattern. In some examples, the firstsegment may include two bends between the first end and the second end.In some examples, the flexible surface may include at least two surfaceswith the first flexible pattern on the first surface and a secondflexible pattern on a second surface. In some examples, the flexiblesurface may include six surfaces each having a flexible pattern. In someexamples, the first end of the first segment may interconnect with threeother segments. In some examples, the second end of the first segmentmay interconnect with three other segments.

In some examples, the flexible surface may be included in a body of oneof an implant and an instrument. In some examples, the body has at leastone non-flexible surface. In further examples, the body may have atleast one smooth surface. In some examples, the body may have at leastone surface with a plurality of projections and a plurality of grooves.In other examples, the plurality of segments may be bordered by cut outsin the body that extend through the body. In some examples, theplurality of segments may be bordered by cut outs in the body thatextend through less than an entirety of the body. In still furtherexamples, the plurality of segments may be bordered by cut outs in thebody and at least two cut outs are oriented at different angles relativeto the flexible surface.

In another aspect, the present disclosure relates to a flexible surfacethat includes a flexible pattern defined by a plurality of material cutouts in the flexible surface. The material cut outs include at least afirst material cut out with a first material cut out line having a firstend and a second end. The plurality of material cut outs are locatedadjacent to one another such that the plurality of material cut outs,combined with one another, form rows and columns over the flexiblesurface.

In some examples, the flexible surface may be included in an implant. Insome examples, the implant may be a fixation member. Where the implantis a fixation member, the fixation member may include an exteriorhelical thread. The fixation member may include a head with a keyedinner surface. The flexible pattern may extend at least half of a lengthof the fixation member. In further examples, the implant may be a rod.In some examples, the implant may be an adjustable cage device. Theadjustable cage device may include an endplate. In some of theseexamples, the endplate may include a flexible pattern. In otherexamples, the endplate may include a channel configured and dimensionedto receive the flexible surface. In some examples where the implant isan adjustable cage device, the adjustable cage device may include ahousing that has a flexible pattern. In others, the adjustable cagedevice may include a support member that includes a flexible pattern. Instill others, the adjustable cage device may include a top surface thatincludes a flexible pattern. In some examples, the implant may be aninterbody adapted for placement in a mammalian spine. In other examples,the flexible surface may be included in an instrument. The instrumentmay be a blade and the blade may be configured and dimensioned toretract tissue.

In some examples, the plurality of material cut outs may be positionedso that an axis through the first material cut out line passes through asecond cut out line on a second material cut out and a third cut outline on a third material cut out, the second and the third material cutouts being immediately adjacent to the first material cut out. In somevariations of this example, the first material cut out may include afirst transverse cut out line with the same shape as the first materialcut out line, the first transverse cut out line crossing a center of thefirst material cut out line and oriented at ninety degrees relative tothe first material cut out line. In other examples, the flexible surfacemay include a second flexible surface with a second flexible patterndifferent from the first flexible pattern. In some examples, theflexible surface may include at least two surfaces with the firstflexible pattern on the first surface and a second flexible pattern on asecond surface. In some examples, the flexible surface may include sixsurfaces each having a flexible pattern.

In some examples, the flexible surface may be included in a body of oneof an implant and an instrument. In some examples, the body has at leastone non-flexible surface. In further examples, the body may have atleast one smooth surface. In some examples, the body may have at leastone surface with a plurality of projections and a plurality of grooves.In other examples, the material cut outs may extend through the body. Infurther examples, the material cut outs extend through less than anentirety of the body. In some example, the plurality of material cutouts may include at least two cut outs that are oriented at differentangles relative to the flexible surface.

In one aspect, the present disclosure relates to a flexible surface witha flexible pattern defined by a plurality of slits. The plurality ofslits are grouped into separate pairs including a first pair and asecond pair. The first pair of slits includes a first slit and a secondslit, the first slit crossing the second slit. The second pair of slitsis adjacent to the first pair of slits and has the same shape as thefirst pair of slits. The plurality of slits define rows and columns.

In some examples, the flexible surface may be included in an implant. Insome examples, the implant may be a fixation member. Where the implantis a fixation member, the fixation member may include an exteriorhelical thread. The fixation member may include a head with a keyedinner surface. The flexible pattern may extend at least half of a lengthof the fixation member. In further examples, the implant may be a rod.In some examples, the implant may be an adjustable cage device. Theadjustable cage device may include an endplate. In some of theseexamples, the endplate may include a flexible pattern. In otherexamples, the endplate may include a channel configured and dimensionedto receive the flexible surface. In some examples where the implant isan adjustable cage device, the adjustable cage device may include ahousing that has a flexible pattern. In others, the adjustable cagedevice may include a support member that includes a flexible pattern. Instill others, the adjustable cage device may include a top surface thatincludes a flexible pattern. In some examples, the implant may be aninterbody adapted for placement in a mammalian spine. In other examples,the flexible surface may be included in an instrument. The instrumentmay be a blade and the blade may be configured and dimensioned toretract tissue.

In some examples, the flexible slits may also include a first curvedportion, a central portion and a second curved portion such that thesecond curved portion is separated from the first curved portion by thecentral portion. In these examples, each of the first and second curvedportions may have a hooked shape. A first axis may extend along aportion of a length of the central portion. The first curved portion maybe on a first side of the first axis and the second curved portion maybe on a second side of the first axis. A second axis transverse to thefirst axis may extend through a center of the central portion such thatthe first curved portion is on a first side of the second axis and thesecond curved portion is on a second side of the second axis.

In some examples, the first slit may cross the second slit atapproximately a midway point on a length of each of the first and secondslits. In some examples, the flexible surface may include at least twosurfaces with the first flexible pattern on the first surface and asecond flexible pattern on a second surface. In some examples, theflexible surface includes six surfaces each having a flexible pattern.

In some examples, the flexible surface is included in a body of animplant or an instrument. In some of these examples, the body mayinclude at least one non-flexible surface. In other examples, the bodymay have at least one smooth surface. In some examples, the body mayhave at least one surface with a plurality of projections and aplurality of grooves. In some examples, the plurality of slits mayextend through the body. In other examples, the plurality of slits mayextend through less than an entirety of the body. In some examples, theplurality of slits may include at least two slits that are oriented atdifferent angles relative to the flexible surface.

In another aspect, the present disclosure relates to an interbodyimplant that includes a body. The body includes a first opening thatdefines a first pathway and a second opening that defines a secondpathway transverse to the first pathway. The first opening is bound by afirst inner surface of the body, the first inner surface being curvedand having a flexible surface region thereon. The flexible surfaceregion includes a continuous segment adjacent to a first slit on oneside and a second slit on a second side and extends from a first end toa second end with at least two bends therebetween.

In some examples, the first slit may be C-shaped and the second slit maybe T-shaped. In some examples, the continuous segment may include aprotrusion in between the first end and the second end. In someexamples, the second opening may be bound by a second inner surface ofthe body, the second inner surface being curved and having a hook-shapedelement extending therefrom to a free end. In some examples, thehook-shaped element may include a tip extending into the second pathwayof the second opening.

Additional objects and advantages of the disclosure will be set forth inpart in the description which follows or may be learned by practice ofthe embodiments of the disclosure.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the embodiments of the disclosure, asclaimed.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure are described herein belowwith reference to the drawings, wherein:

FIG. 1A is an isometric view of an interbody.

FIG. 1B is a side view of FIG. 1A.

FIG. 1C is a top view of FIG. 1A.

FIG. 2A illustrates an example of a flexible pattern.

FIG. 2B illustrates another example of the flexible pattern of FIG. 2A.

FIG. 3A illustrates an example of a flexible pattern.

FIG. 3B illustrates another example of the flexible pattern of FIG. 3A.

FIG. 4A illustrates an example of a flexible pattern.

FIG. 4B illustrates another example of the flexible pattern of FIG. 4A.

FIG. 5A illustrates an additional example of the flexible patternaccording to other aspects.

FIG. 5B illustrates a top view of a surface including the flexiblepattern of FIG. 5A.

FIG. 5C illustrates an additional example of the flexible patternaccording to other aspects.

FIG. 5D illustrates a top view of a surface including the flexiblepattern of FIG. 5C.

FIGS. 6-10 illustrate still further examples of a flexible pattern.

FIG. 11A is an isometric view of an aspect of an interbody with aflexible pattern.

FIG. 11B is a side view of FIG. 11A.

FIG. 11C is a front view of FIG. 11A.

FIGS. 12A-D illustrate a top view of an interbody with various flexiblepatterns.

FIG. 13A is an isometric view of an interbody with a flexible pattern.

FIG. 13B is a top view of FIG. 13A.

FIG. 13C is an isometric view of an interbody with a flexible patternaccording to another aspect.

FIG. 13D is a side view of FIG. 13C.

FIG. 14A is an isometric view of an interbody with a flexible pattern.

FIG. 14B is a top view of FIG. 14A.

FIG. 14C is a side view of FIG. 14A.

FIG. 14D is a front view of FIG. 14A.

FIG. 15A is an isometric view of an interbody with a flexible patternaccording to an aspect.

FIG. 15B is a side view of FIG. 15A.

FIGS. 16A-C are a side view illustrating degrees of curvature of asurface including a flexible pattern.

FIGS. 17A-C are isometric views of FIGS. 16A-C, respectively.

FIG. 18 is a cross sectional view of an interbody with angled gapsdefining a flexible pattern.

FIGS. 19A-B are front views of a fixation member in different states offlexure according to one embodiment of the disclosure.

FIG. 19C is a side view of the fixation member of FIGS. 19A-B.

FIGS. 20A-B are isometric and front views, respectively, of a flexibleinstrument according to one embodiment of the disclosure.

FIG. 20C is a perspective view of the flexible instrument of FIGS. 20A-Bin a retraction system according to one embodiment of the disclosure.

FIGS. 21A-D are views of a rod according to one embodiment of thedisclosure.

FIGS. 21E-F are isometric views of a rod according to one embodiment ofthe disclosure.

FIGS. 21G-H are isometric views of a rod according to one embodiment ofthe disclosure.

FIGS. 21I-J are isometric views of a rod according to one embodiment ofthe disclosure.

FIGS. 21K-L are isometric views of a rod according to one embodiment ofthe disclosure.

FIG. 22A is an exploded view of an adjustable cage according to oneembodiment of the disclosure.

FIG. 22B is an isometric view of the adjustable cage of FIG. 22A.

FIG. 22C is a top view of one example of an endplate for the adjustablecage of FIG. 22A.

FIG. 23A is an isometric view of an adjustable cage according to oneembodiment of the disclosure.

FIG. 23B is a top view of the adjustable cage of FIG. 23A.

FIGS. 23C-D are side views of the adjustable cage of FIG. 23A.

FIGS. 24-26 are perspective views of an interbody implant according toone embodiment of the disclosure.

FIGS. 27-28 are top and perspective views of a plate according to oneembodiment of the disclosure.

FIGS. 29-30 are top and perspective views of a plate according to oneembodiment of the disclosure.

FIG. 31 is a side view of a femoral implant included as part of a kneeimplant system according to one embodiment of the disclosure.

FIGS. 32-35 are various views of an interbody implant according to oneembodiment of the disclosure.

DETAILED DESCRIPTION

Various embodiments will now be described in detail with reference tothe drawings, wherein like reference numerals identify similar oridentical elements. Additionally, in the drawings and in the descriptionthat follows, terms such as front, rear, upper, lower, top, bottom, andthe similar directional terms are used simply for convenience ofdescription and are not intended to limit the disclosure attachedhereto.

In the drawings and in the description that follows, the term “proximal”refers to the portion of the device that is closest to the operator,while the term “distal” refers to the portion of the device that isfurthest from the operator. Additionally, in the drawings and in thedescription that follows, terms such as front, rear, upper, lower, top,bottom, and the similar directional terms are used simply forconvenience of description and are not intended to limit the disclosureattached hereto. In addition, the term “cephalad” is used to indicate adirection toward a patient's head, whereas the term “caudad” indicates adirection toward the patient's feet. Further still, the term “medial”indicates a direction toward the middle of the body of the patient,whilst the term “lateral” indicates a direction toward a side of thebody of the patient (i.e., away from the middle of the body of thepatient). The term “posterior” indicates a direction toward thepatient's back, and the term “anterior” indicates a direction toward thepatient's front. In the following description, well-known functions orconstructions are not described in detail to avoid obscuring the presentdisclosure in unnecessary detail.

Flexible Interbody

In one aspect, the present disclosure is directed an interbodycomprising at least one surface with a flexible pattern, wherein theflexible pattern includes a continuous line of material. The flexibilityof a surface can be determined by various techniques includingdetermining the stiffness of a surface, i.e., the resistance of asurface to elastic deformation. Stiffness is a measure of the appliedforce divided by the deflection of the surface. Variables associatedwith the flexible pattern can alter the stiffness of the surface. Byselecting certain variables, a specific stiffness can be achieved inresponse to a given load. The flexible pattern can provide a stiffnessto a surface that can be measured, for example, using a compressiveload. The stiffness of a surface including a flexible pattern relativeto another surface without the flexible pattern can vary from about 25%to about 100%, for example, from about 35% to about 90%, and as afurther example from about 50% to about 80%.

Referring now to FIGS. 1A-1C, 11A-11C, 13A-13D, 14A-14D, and 15A-15B,there is disclosed an embodiment of an interbody 100 for engagementbetween vertebrae. As can be seen from the various Figures, an interbody100 can have various configurations and the present application isintended to cover various configurations such as those illustrated inthe Figures. The interbody 100 can have at least one surface, such astwo surfaces each independently with a flexible pattern 200. In anaspect, the interbody 100 can have up to six surfaces each independentlywith a flexible pattern 200. The interbody 100 includes a body 102having a substantially contoured first end surface 104 at a distal orleading end of the body 102 and a second end surface 108 oppositethereto at a proximal or trailing end of the body 102. The body 102extends between the first and second end surfaces 104 and 108 to definerespective top and bottom vertebral engaging surfaces 112 a, 112 b, aswell as opposed side surfaces 162 a, 162 b. The top and bottom vertebralengaging surfaces 112 a, 112 b are disposed opposite to one another.

The body 102 can be configured such that the top and bottom vertebralengaging surfaces 112 a, 112 b intersect the side surfaces 162 a, 162 b,respectively, to provide a substantially quadrilateral cross-sectionwith rounded corners 140, as illustrated in FIGS. 13A, 13C, 13D, and14D. The body 102 has, by way of example, a substantially rectangularcross-section, although other quadrilateral shapes such as a square arealso contemplated, as illustrated in FIGS. 11A-11C. In addition, thecross-section shape may also be hexagonal or other suitable multilateralshape. The shape of the body 102 is not limited in this context.

In another aspect, the body 102 can be configured such that the top andbottom vertebral engaging surfaces 112 a, 112 b intersect posts 106, toprovide support to the body 102 with minimal structural elements, asillustrated in FIGS. 14A, 14C and 14D. The posts 106 can be located at acorner of the body, as illustrated in FIGS. 11A-C. In another aspect, apost 106 a can extend from the top vertebral engaging surface 112 a, andanother post 106 b can extend from the bottom engaging surface 112 bwith a gap 110 between the posts 106 a, 106 b, as illustrated in FIGS.13A, 13C, and 13D. In another aspect, the post 106 can be located atfirst end surface 104, as illustrated in FIGS. 1A and 1B. The post 106can be located anywhere between the top and bottom vertebral engagingsurfaces 112 a, 112 b. The body 102 can include more than one post 106.The post 106 can provide support to the body 102 while reducing theamount of material needed to make the body 102, and increasing the openspace within the body 102 to allow for bone ingrowth.

The body 102 can also be configured such that the top and bottomvertebral engaging surfaces 112 a, 112 b have a convex profile, asillustrated in FIGS. 1A, 1B, 11A-11C, 13A, 13C, 14A, and 15B. In anotheraspect, the body 102 can be configured so that the top and bottomvertebral engaging surfaces 112 a, 112 b have a flat, planar profile; aconvex profile, or a profile that varies across a length of the body102. The body 102 can be configured to be symmetrical around acenterline axis X-X that extends from the first end 104 to the secondend 108. The body 102 can be configured so that the side surfaces 162 a,162 b have an atraumatic blunt nose profile with respect to thecontoured first end 104.

In an aspect, the top and bottom vertebral engaging surfaces 112 a, 112b can be the same or different. In particular, each of the top andbottom vertebral engaging surfaces 112 a, 112 b can independently have asmooth configuration or a plurality of protrusions 122 in a particularconfiguration. A smooth configuration is shown in FIGS. 11A-11C,14A-14D, and 15A-15B. As shown in FIGS. 1A-1C, and 13A-13D, theplurality of protrusions 122 define a set of grooves 124 that facetowards the second end 108. Each groove of the set of grooves 124 has aposition along the top and bottom vertebral engaging surfaces 112 a, 112b. Each groove of the set of grooves 124 includes a first face that isorthogonal to the top and bottom vertebral engaging surfaces 112 a, 112b, i.e., to the axis X-X, at the respective position of the groove. Eachgroove of the set of grooves 124 includes a second opposing face thatcan be sloped or inclined with respect to the top and bottom vertebralengaging surfaces 112 a, 112 b so that the surfaces converge at thebottom of the groove 124.

The interbody 100 can comprise at least one surface with a flexiblepattern 200, in which the flexible pattern 200 includes a continuousline of material. As discussed herein, the interbody 100 can include topand bottom vertebral engaging surfaces 112 a, 112 b, post 106, sidesurfaces 162 a, 162 b, first end 104, and second end 108. The interbody100 can include at least two surfaces each with a flexible pattern 200,as shown in FIGS. 1A, 1B, 13A, 13C, 14A, 14C, and 14D. In an aspect, theinterbody 100 can have one, two, three, four, five, or up to sixsurfaces each independently with a flexible pattern 200. For example,the interbody 100 can include a top surface 112 a with a flexiblepattern 100, a bottom surface 112 b with a flexible pattern 200, firstend 104 and second end 108 each with a flexible pattern 200, and twoside surfaces 162 a, 162 b with a flexible pattern 200.

Each surface of the interbody 100 can be independent from any othersurface of the interbody 100 in terms of variables, such as degree offlexibility, degree of rigidity, density of the flexible pattern 200,form of the flexible pattern 200, thickness of the surface including theflexible pattern 200, and etc. One of these variables may impact anothervariable. For example, a thick top surface 112 a with a flexible pattern200 can have a higher degree of rigidity as compared to a thin bottomsurface 112 b with a flexible pattern 200 within the same interbody 100.

FIGS. 16A-C illustrate the side view of, for example, a surface having aflexible pattern 200, as shown in FIGS. 17A-C, respectively. FIG. 16Aillustrates a surface that is thicker than a surface as shown in FIG.16B, which is thicker than a surface as shown in FIG. 16C. FIGS. 16A-Cand FIGS. 17A-C illustrate that a thin surface with a flexible pattern200 (see, e.g., FIGS. 16C and 17C) can have a greater degree offlexibility as compared to a thicker surface with a flexible pattern 200(see, e.g., FIGS. 16A and 17A).

As another example, of how one variable of the flexible pattern 200 caneffect another variable of the flexible pattern 200, an end surface 108can have a dense flexible pattern 200 including curved line as shown inFIG. 3B, a side surface 162 a can have a less dense flexible pattern 200comprising squared lines as shown in FIG. 2A, and a top surface 112 acan have a varied thickness across the length of the interbody as shownin FIG. 15B. It is appreciated that each surface with a flexible pattern200 of an interbody 100 can be designed to meet the requirements for itsparticular use.

As shown in FIGS. 2A, 2B, 3A, 3B, 4A, 4B, and 5A-5D, the flexiblepattern 200 can include a continuous line of material. As shown in FIGS.2A, 2B, 3A, 3B, 4A, 4B, and 5A-5D the shaded area is the continuous lineof material forming the flexible pattern 200. The white area is theabsence of material. The flexible pattern 200 can include a plurality ofsegments 202 that interconnect to form rows and columns A segment 202can include a first end and a second end in which the first end of eachsegment 200 can interconnect with at least one second end of anothersegment of the plurality of segments, for example in an adjacent row orcolumn. In an aspect, a first end of a segment 202 can interconnect withthree different segments to form the flexible pattern 200 with acontinuous line of material. In a further aspect, a second end of asegment 202 can interconnect with three different segments to form theflexible pattern 200 with a continuous line of material.

In another aspect as shown in FIG. 5A, the segment 202 can fliporientations within the continuous line of material so that in a firstconfiguration the segment forms rows and in an adjacent secondconfiguration the segment forms columns. The flexible pattern can alsoincrease in size. For example, as shown in FIG. 5A, the innermostcolumns and rows are smaller in size than the outermost columns androws. Accordingly, the stiffness in the interior of the flexible pattern200 is expected to be lower than a stiffness along the outer edges,e.g., perimeter, of the flexible pattern 200. The flexible pattern 200illustrated in FIG. 5A can be a single continuous radius across anentire or a portion of a surface. In another aspect, the flexiblepattern 200 illustrated in FIG. 5A can be multiple separate squaresacross an entire or a portion of a surface, as shown in FIG. 5B.

In another aspect as shown in FIG. 5C, the flexible pattern 200 mayinclude a plurality of segments that interconnect to mimic a pattern ofcortical bone. The segments switch back and forth in an arching patternand/or curlicue pattern. The stiffness in the interior of the flexiblepattern 200 is expected to be higher than a stiffness along the outeredges, e.g., perimeter, of the flexible pattern 200. The flexiblepattern 200 illustrated in FIG. 5C can be a single continuous radiusacross an entire or a portion of a surface. In another aspect, theflexible pattern 200 illustrated in FIG. 5C can be multiple separatespheres across an entire or a portion of a surface, as shown in FIG. 5D.

The flexible pattern 200 can flex under application of a force. In anaspect, a first area of the flexible pattern 200 can move in a directionrelative to a second area of the flexible pattern 200 under an appliedforce.

As shown in FIGS. 2A, 2B, and 5A, the flexible pattern 200 can include acontinuous line of material that forms corners, which can be used toform smaller or denser patterns. A flexible pattern 200 with corners canbe harder to manufacture. As shown in FIGS. 3A, 3B, 4A, 4B, and 5C, theflexible pattern 200 can comprise curves, arches, and/or curlicues,which can be used to form larger or less dense patterns. A flexiblepattern 200 with curves, arches, and/or curlicues can be easier tomanufacture.

Other examples of flexible patterns with continuous lines of materialare shown in FIGS. 6, 8, 9 and 10. FIG. 6 illustrates a flexible pattern200 with a plurality of segments 202 in the form of swirls spaced arounda central region. In the variation shown, there are four swirls intotal, each one including a continuous line of material left fromcutting a larger interbody structure. The continuous line of materialextends from an outer dimension and spirals inward toward a center ofthe swirl. Each continuous line of material originates in a centermaterial region centered between the swirls and includes a plurality ofopenings therein. In a variant, the central region may be solid andwithout swirls. FIG. 6 illustrates that each swirl is circumferentiallyoffset with respect to the others around the center material region andeach swirl is approximately the same distance from the center materialregion. In one variant, the flexible pattern 200 of FIG. 6 may becomprised of different materials, such as materials alternating witheach continuous line. In this manner, the flexible pattern may belamellar.

In FIG. 8, the flexible pattern 200 is defined by a continuous line ofmaterial defining an “S” shape. The flexible pattern includes twoseparate segments 202 in the form of swirls. Each continuous line ofmaterial is defined by a pair of material cut outs spiraling outwardfrom a center of a respective spiral. At an outer perimeter of thespiral, the pair of cut outs extend across a central region to anopposing swirl. Each swirl has a similar structure, and both include acontinuous line of material defined by a pair of cut outs that extendfrom a center of the swirl in a counterclockwise direction. Of course, adirection of one or both of the continuous lines of material from thecenter of the swirls may be reversed. FIG. 9 illustrates anotherflexible pattern 200 with three segments 202 combined so that theflexible pattern has a generally triangular shape. Each segment 202 isin the form of a swirl and is defined by a continuous line of materialspiraling outward from a center of the respective swirl.

FIG. 10 illustrates yet another flexible pattern 200 in the form of asingle spiral surrounded by solid material. A continuous line ofmaterial defines the spiral in this configuration.

The continuous line of material can be any biocompatible material, suchas a metal, an alloy, a polymer, and combinations thereof, such as ablend of a metal and a polymer. The continuous line of material can havea uniform width. In an aspect, a width of the continuous line ofmaterial can vary. In an aspect, the continuous line of material caninclude straight areas and/or curved areas.

In yet another arrangement, a flexible pattern includes a plurality ofconcentric cut outs as shown in FIG. 7. At a center of each segment 202is an opening abutted externally by a ring shaped portion of material,then a second opening having a ring shape, and so on. As shown, segmentshapes may be overlapping. In other variations, solid material may existin between each segment or the segments may be equal to one or more ofthe other segments and directly abut one another. Further variationsbased on the illustrated patterns are also contemplated.

In an aspect, the gaps, also referred to herein as cut outs, in theinterbody 100 that define the flexible pattern can be oriented at anacute angle relative to a surface of the interbody 100, as shown in FIG.18, for example. The gaps within a group of gaps may be oriented atvarying angles to control a bias in the direction of flexibility of theinterbody implant. For example, where a body of an implant includes tengaps at one location on its length, three of these may be at a singleacute angle relative to a surface of the body while seven may beperpendicular to the surface. In another example, two may be at a firstangle, five may be at a second angle, while another three may be at athird angle. The gaps oriented at the same angle may be adjacent to oneanother or separated from one another. As these examples illustrate, thepossible combinations of gap configurations is significant. Because theorientation of the gap(s) may alter the flexural properties of thematerial, it follows that the number of possibilities for apredetermined bias in deformation in any one or more parts of a surfaceis significant.

In any of the contemplated embodiments, cut outs that define theflexible pattern may be formed entirely through a thickness of the bodyof the implant. Alternatively, the cut outs may be formed through only aportion of the thickness of the body. In further alternatives, someflexible patterns may be defined by cut outs entirely through thethickness while others are formed through only a portion of thethickness. In still further alternatives, any one flexible pattern mayinclude a first portion with cut outs through the thickness of the bodyand a second portion with cut outs through only part of a thickness ofthe body.

The at least one surface including a flexible pattern 200 can be formedby known manufacturing methods, such as additive layer manufacturing,e.g., three-dimensional printing, chemical etching, photo etching, lasercutting, water jet cutting, and traditional machining, etc. Examples ofadditive layer manufacturing (ALM) techniques include electron beammelting, selective laser sintering (SLS), selective laser melting (SLM),and other three-dimensional (3-D) processes. When employing thesetechnologies, articles are produced in layer-wise fashion from alaser-fusible powder that is dispensed one layer at a time. The powderis sintered in the case of SLS technology and melted in the case of SLMtechnology, by the application of laser energy that is directed inraster-scan fashion to portions of the powder layer corresponding to across section of the article. After the sintering or melting of thepowder on one particular layer, an additional layer of powder isdispensed, and the process repeated, with sintering or melting takingplace between the current layer and the previously laid layers until thearticle is complete. In one example, a high energy beam is emitted froma beam-generating apparatus to heat metal powder sufficiently to sinterand preferably to at least partially melt or fully melt the metalpowder. High energy beam equipment for manufacturing such structures maybe one of many commercially available. The beam generation equipment mayalso be a custom-produced laboratory device. Detailed descriptions ofthe SLS technology may be found in U.S. Pat. Nos. 4,863,538, 5,017,753,5,076,869, and 4,944,817, the entire disclosures of which areincorporated by reference herein. Similarly, a detailed description ofthe use of SLM technology may be found in U.S. Pat. No. 7,537,664 (“the'664 patent”), the disclosure of which is incorporated by referenceherein. The SLM and SLS technologies enable direct manufacture of solidor porous three-dimensional articles of high resolution and dimensionalaccuracy from a variety of materials including wax, metal and metalalloys, metal powders with binders, polycarbonate, nylon, other plasticsand composite materials, such as polymer-coated metals and ceramics.

Other non-powder based additive manufacturing technologies are alsoknown to produce high resolution and dimensionally accurate articles.For example, in fused filament fabrication (FFF) or Plastic Jet Printing(PJP), strands of molten material are extruded from a nozzle to formlayers onto a substrate in which the material hardens upon extrusion.Using digital light processing (DLP), photosensitive resin plastic iscured by light and built layer by layer from the bottom-up or a vat ofliquid polymer is exposed to balanced levels of ultraviolet light andoxygen to produce a part often from the top-down. In inkjet 3D printing,a liquid binding material is selectively deposited across a thin layerof a powder and the process is repeated in which each new layer isadhered to the previous layer.

As shown in FIGS. 12A-12D, the flexible pattern 200 can be the same ordifferent and/or can be present or absent across the at least onesurface of the interbody 100. In an aspect, the flexible pattern 200 canbe present across the entire surface, as shown in FIG. 12A, or can bepresent in sections (i.e., can be absent in sections) of the at leastsurface, such as shown in FIGS. 12B-12D. In another aspect, the flexiblepattern 200 can be present in a section to form a perimeter 206 of theat least one surface without being present at an interior of the atleast one surface, as shown FIG. 12C. The flexible pattern 200 can alsobe present in an interior 208, without extending to one or more edges,to form a center of the at least one surface, as shown in FIGS. 12B and12D.

The flexible pattern 200 can transition from a perimeter to an interiorso that the perimeter is more flexible than the interior and vice versa.For example, the flexible pattern 200 can transition from a less dense,i.e., farther apart, pattern at a perimeter to a more dense, i.e.,closer together, pattern at an interior of the at least one surface. Asa further example, the flexible pattern 200 can transition from a moredense, i.e., closer together, pattern at a perimeter to a less dense,i.e., farther apart, pattern at an interior of the at least one surface.The transition of the flexible pattern 200 can be equivalent from aperimeter to an interior and vice versa. The transition of the flexiblepattern 200 can be graduated so that there are gradient zones of varyingflexibility across the at least one surface.

The at least one surface can include alternating sections. For example,a first section of the at least one surface can be more rigid. A secondsection can be adjacent to the first section and can be more flexible.The number of alternating rigid and flexible sections can vary. The atleast one surface can be more rigid depending upon variables, such asthe density of the pattern and/or the thickness of the material used toform the pattern. Similarly, the at least one surface can be moreflexible with, for example, a less dense pattern and/or a thinnermaterial used to form the pattern. In another aspect, the at least onesurface can include an alternating section of a first section with aflexible pattern 200 and a second section without a flexible pattern200.

The at least one surface can have a uniform thickness, such as shown inthe top engaging surface 112 a in FIG. 11B. In another aspect, the atleast one surface can have a thickness that varies, such as shown in thetop engaging surface 112 a in FIG. 15B. The thickness can vary bysections. For example, the at least one surface can have a first sectionthat is thin adjacent to a second section that is thick (compared to thefirst section). The thin/thick sections can alternate across the atleast one surface and can affect the flexibility of the at least onesurface. In another aspect, the thickness can vary along a gradient ofthe at least one surface, such as from thick to thin or vice versa. Itis expected that a section of the at least one surface that is thickerthan another section will also be more rigid. Similarly, it is expectedthat a section of the at least one surface that is thinner than anothersection will also be more flexible, as shown in FIGS. 16A-C and FIGS.17A-C.

Notwithstanding the presence of the flexible pattern 200, the at leastone surface can be smooth or include the plurality of projections 122. Asmooth surface can be even and regular, i.e., it does not include anyprojections 122 from the at least one surface. An array of projections122 can inhibit movement of the interbody 102 when positioned in place.In an aspect, the interbody 100 has at least one smooth surface. Inanother aspect, the interbody 100 has at least one smooth surface with aflexible pattern. In another aspect, the interbody 100 has a least onesurface with a flexible pattern and a plurality of projections. Inanother aspect, the interbody has at least one surface with a pluralityof projections.

In an aspect, the interbody 100 can be symmetric. For example, theinterbody 100 can be symmetric with respect to two surfaces each with aflexible pattern 200, e.g., can have the exact same surface and flexiblepattern 200 opposite one another, such as a top surface 112 a with aflexible pattern 200 that is exactly the same in all variables as abottom surface 112 b with a flexible pattern 200.

In another aspect, the interbody 100 can be asymmetric. For example, theinterbody 100 can be asymmetric with respect to two surfaces with aflexible pattern 200, e.g., can have a different surface with a flexiblepattern 200 opposite one another, such as a top surface 112 a that isdifferent with respect to one variable as a bottom surface 112 b.

In an aspect, the interbody 100 can include at least one surface and atleast one post 106. For example, the at least one post 106 can bepositioned under a center of the interior of the at least one surface,as shown in FIGS. 11B and 11C. As a further example, the interbody 100can include at least one surface 112 a and at least one non-flexiblesurface 112 b that are separated from one another by four posts 106 at acorner of each surface, as shown in FIGS. 11A-11C. The non-flexiblesurface can be smooth or can include a plurality of grooves. In anotheraspect, the interbody 100 can include any number of posts 106, such astwo posts, three posts, four posts, etc. The posts 106 can be locatedanywhere within the interbody, such as anywhere between surfaces 112 a,and 112 b, such as along the perimeter and/or within the interior.

The interbody 100 can include at least one surface having a radius ofcurvature forming a curved surface. The curved surface can be a smoothsurface or a surface having an array of projections 122. The curvedsurface can also be at least one surface with a flexible pattern 200.The curved surface can have a radius of curvature defining a convexsurface. The curved surface can have a radius of curvature defining aconcave surface. If the interbody 100 includes two or more curvedsurfaces, each curved surface may be the same or different. For example,the radius of curvature can be the same or different for each curvedsurface.

In another aspect, the interbody 100 can be distractible. Distractibleinterbodies are described in the following U.S. patents, the entirety oftheir disclosures are hereby incorporated by reference: U.S. Pat. Nos.8,303,663; 8,932,302; 8,636,746; 8,771,360; 9,358,125; 9,474,626; and9,498,270.

The interbody 100 can be filled with a bone support matrix. As usedherein, a “bone support matrix” is a material that facilitatesosteogensis. Suitable bone support matrices can be resorbable ornonresorbable and osteoconductive or osteoinductive. Non-limitingexamples of suitable bone support matrices include synthetic materials,bone morphogenic proteins (BMPs), and heterologous, homologous, orautologous bone and derivatives thereof. The bone support matrix may beradiolucent on x-rays.

In another aspect, the flexible interbody 100 is included in a method ofplacing an implant between vertebrae in a spine.

Through the inclusion of a flexible pattern on an interbody, engagementof the interbody with adjacent vertebrae is improved. In particular,surfaces of the interbody deform to adapt to the contours of the bonesurfaces so that a close fit is obtained.

Fixation Member

In another aspect, the present disclosure is directed to a fixationmember 300, including a head 312, and at least one surface with aflexible pattern 400, wherein the flexible pattern includes a continuousline of material. The flexibility of a surface can be determined byvarious techniques including determining the stiffness of a surface,i.e., the resistance of a surface to elastic deformation. Stiffness is ameasure of the applied force divided by the deflection of the surface.Variables associated with the flexible pattern can alter the stiffnessof the surface. By selecting certain variables, a specific stiffness canbe achieved in response to a given load. The flexible pattern canprovide a stiffness to a surface that can be measured, for example,using a compressive load. The stiffness of a surface including aflexible pattern relative to another surface without the flexiblepattern can vary from about 25% to about 100%, for example, from about35% to about 90%, and as a further example from about 50% to about 80%.

As shown in FIGS. 19A, 19B, and 19C, the head 312 of the fixation member300 can be any shape, such as cylindrical, cupped, squared, polygonal,etc., so long as it can be used to manipulate the fixation member 300into an osseous tissue. The head 312 can include an exterior helicalthread with surfaces that can engage with osseous tissue. Alternatively,the head 312 can include a smooth surface. In another aspect, the head312 can include an outer roughened surface to enhance the grip of a userand/or attachment of a screw assembly (not shown). Additionally, thehead 312 may be configured and dimensioned, such as including amulti-faceted inner surface or can be keyed, to receive a driver (notshown).

The head 312 can extend from a proximal end of the fixation member 300into a body 314. The body 314 can extend from the head 312 to a distalend 316 of the fixation member 300. In an aspect, the body 314 caninclude a consistent diameter throughout a length of the body. Inanother aspect, the body 314 can taper from the head 312 to the distalend 316 of the fixation member 300. The body 314 of the fixation member10 can include an exterior helical thread with surfaces that can engagewith osseous tissue. The exterior helical thread of the body 314 may besame or different from the exterior helical thread of the head 312. Forexample, the exterior helical thread of the head 312 may form a tighter,denser helix as compared to the exterior helical thread of the body 314or vice versa. Alternatively, the body 314 can include a smooth surface.

The body 314 of the fixation member 300 can include a surface with aflexible pattern 400. The flexible pattern 400 can extend at least aquarter of a length of the fixation member 300. In another aspect, theflexible pattern 400 can extend at least a half of a length of thefixation member 300. The fixation member 300 can be configured anddimensioned to bend and/or flex when under stress, such as an appliedforce.

The distal end 316 of the fixation member 300 can have a blunt end or apointed end. The distal end 316 can also include any exterior helicalthread that extends from the body 314. In another aspect, the distal end316 can include a non-flexible surface, e.g., a surface absent theflexible pattern 400.

The fixation member 300 can include at least one surface with a flexiblepattern 400, in which the flexible pattern 400 includes a continuousline of material.

The fixation member 300 may be varied in many ways. As shown in FIG.19C, the flexible pattern 400 can be present on the body 314 with anon-flexible surface 318. In another aspect, the flexible pattern 400can be present on the entire body 314 without a non-flexible surface318.

The flexible pattern of material on the fixation member may be varied inmany ways, such as those shown in FIGS. 2A, 2B, 3A, 3B, 4A, and 4B. Inthese variations, the flexible pattern of fixation member 300 shown inFIGS. 19A-C may be substituted with flexible pattern 200 shown in anyone of FIGS. 2A, 2B, 3A, 3B, 4A and 4B. The flexible patterns 200 caninclude a continuous line of material. As shown in FIGS. 2A, 2B, 3A, 3B,4A, and 4B, the shaded area is the continuous line of material formingthe flexible pattern 200. The white area is the absence of material. Theflexible pattern 200 can include a plurality of segments 202 thatinterconnect to form rows and columns. A segment 202 can include a firstend and a second end in which the first end of each segment 202 caninterconnect with at least one second end of another segment 202 of theplurality of segments 202, for example in an adjacent row or column. Inan aspect, a first end of a segment 202 can interconnect with threedifferent segments to form the flexible pattern 200 with a continuousline of material. In a further aspect, a second end of a segment 202 caninterconnect with three different segments to form the flexible pattern200 with a continuous line of material.

In another aspect as shown in FIG. 5A, the segment 202 can fliporientations within the continuous line of material so that in a firstconfiguration the segment 202 forms rows and in an adjacent secondconfiguration the segment 202 forms columns. The flexible pattern canalso increase in size. For example, as shown in FIG. 5A, the innermostcolumns and rows are smaller in size than the outermost columns androws. Accordingly, the stiffness in the interior of the flexible pattern200 is expected to be lower than a stiffness along the outer edges,e.g., perimeter, of the flexible pattern 200.

As shown in FIGS. 2A, 2B, and 5A, the flexible pattern 200 can include acontinuous line of material that forms corners, which can be used toform smaller or denser patterns. A flexible pattern 200 with corners canbe harder to manufacture. As shown in FIGS. 3A, 3B, 4A, and 4B, theflexible pattern 200 can comprise curves, arches, and/or curlicues,which can be used to form larger or less dense patterns. A flexiblepattern 200 with curves, arches, and/or curlicues can be easier tomanufacture.

The continuous line of material can be any biocompatible material, suchas a metal, an alloy, a polymer, and combinations thereof, such as ablend of a metal and a polymer. The continuous line of material can havea uniform width. In an aspect, a width of the continuous line ofmaterial can vary. In an aspect, the continuous line of material caninclude straight areas and/or curved areas.

In further variations, the flexible pattern may also be as shown inFIGS. 6-10 and described above. The cut outs of the flexible pattern mayall be perpendicular to a surface with the flexible pattern, some may beat an acute angle relative to the surface, or the cut outs may be anycombination of orientations as described above. Further, the cut outsmay be partially or entirely through a thickness of the structure, suchas an outer wall structure, as described above.

The flexible pattern 400 can flex under application of a force orstress. In an aspect, a first area of the flexible pattern 400 can movein a direction relative to a second area of the flexible pattern 400under an applied force, as shown in FIG. 19B. The distal end of theflexible pattern 400 in the body 314 moves in a direction away from theproximal end of the flexible pattern 400 in the body 314.

The fixation member 300 can be formed by known manufacturing methods,such as additive layer manufacturing, e.g., three-dimensional printing,chemical etching, photo etching, laser cutting, water jet cutting, andtraditional machining, etc. Additive layer manufacturing may beperformed in any of the ways described above, for example.

The flexible pattern 400 can be the same or different and/or can bepresent or absent across the at least one surface of the fixation member300. In an aspect, the flexible pattern 400 can be present across theentire surface or can be present in sections, as shown in FIG. 19C(i.e., can include a non-flexible surface 318) of the at least onesurface.

The flexible pattern 400 can transition from a less dense, i.e., fartherapart, pattern at a proximal end of the body 314 to a denser, i.e.,closer together, pattern at a distal end of the body 314. The transitionof the flexible pattern 400 along a length of the body 314 can beequivalent from a proximal end to a distal end of the body 314 and viceversa. The transition of the flexible pattern 400 can also be graduatedso that there are gradient zones of varying flexibility across the body314 of the fixation member 300.

A method of using the fixation member 300 includes, forming an insertionhole in osseous tissue, such as a vertebra. For example, a user can usea drill or probe to form the insertion hole. Alternatively, a user canprobe the osseous tissue using the fixation member 300 itself using adriver (not shown). The fixation member 300 can be inserted into theinsertion hole. In an aspect, the fixation member 300 can be insertedinto the insertion hole until the head 312 is within the vertebra. Auser can then affix a driver (not shown) into the head 312 of thefixation member 300 and apply a force to the driver. The applied forcecan rotate the fixation member 300 about its longitudinal axis so thatthe exterior helical threads of the body 314 and/or the head 312 engagewith the osseous tissue. If the fixation member 300 experiences stress,for example, by the distal end 316 abutting the osseous tissue, thefixation member 300 will flex/bend under the force, as shown in FIG.19B, and will not breach the osseous tissue. A user can apply anopposite force to disengage the exterior helical threads to adjustplacement of the fixation member 300 or to remove it completely.

Through the inclusion of a flexible pattern on a fixation member, thefixation member is advantageous as it provides a greater number ofpossibilities for an insertion angle and ultimately reduces the size ofincision required to implant the fixation member.

Flexible Instrument

In one aspect, the present disclosure is directed to a flexibleinstrument 500 comprising at least one surface with a flexible pattern600, wherein the flexible pattern 600 includes a continuous line ofmaterial. The flexible instrument 500 can be any instrument with the atleast one surface with a flexible pattern 600, such as a retractorblade. The flexibility of a surface can be determined by varioustechniques including determining the stiffness of a surface, i.e., theresistance of a surface to elastic deformation. Stiffness is a measureof the applied force divided by the deflection of the surface. Variablesassociated with the flexible pattern 600 can alter the stiffness of thesurface. By selecting certain variables, a specific stiffness can beachieved in response to a given load. The flexible pattern 600 canprovide a stiffness to a surface that can be measured, for example,using a compressive load. The stiffness of a surface including aflexible pattern 600 relative to another surface without the flexiblepattern can vary from about 25% to about 100%, for example, from about35% to about 90%, and as a further example from about 50% to about 80%.

The flexible instrument 500 can include an arm 512, and an elongatedportion 514, as shown in FIGS. 20A-20C. The arm 512 can be configuredand dimensioned to engage with a retraction system 518, as shown in FIG.20C. The arm 512 can include a connecting pin 538, as shown in FIG. 20C,which can enable connection with the retraction system 518.

The elongated portion 514 can extend from the arm 512. The elongatedportion 514 can include any height and width so long as the elongatedportion 514 does not inhibit a view of a surgical field. In an aspect,the height and width of the elongated portion 514 should be configuredand dimensioned to improve retraction of tissue in a surgical field.

In an aspect, the elongated portion 514 can include a distal end 516.The distal end 516 can include a curved surface. In an aspect, thecurved surface of the distal end 516 can be configured and dimensionedto engage with tissue. For example, the distal end 516 can include aplurality of teeth 520.

The elongated portion 514 of the flexible instrument 500 can have atleast one surface including a flexible pattern 600. In an aspect, theflexible pattern 600 can be present across the entire surface of theelongated portion 514, as shown in FIGS. 20A-20C, and in FIG. 12A forflexible pattern 200, or can be present in sections. For example, theextent of the flexible pattern for flexible instrument 500 shown inFIGS. 20A-C may be substituted with flexible pattern 200 shown in anyone of FIGS. 12B-12D. In this manner, the elongated portion 514 caninclude a section of the surface of the elongated portion 514 with aflexible pattern 200, and can include a non-flexible surface 118, i.e.,a surface of the elongated portion 14 without a flexible pattern 200, asshown in FIGS. 12B-12D. The non-flexible surface 118 of the elongatedportion 514 can provide stability to the flexible instrument 500 and caninfluence the direction of flexibility of the flexible instrument 500.

The flexible pattern 600 can extend at least a quarter of a length ofthe elongated portion 514. In another aspect, the flexible pattern 600can extend at least a half of a length of the elongated portion 514. Inan aspect, the flexible pattern 600 can extend an entire length of theelongated portion 514, such as from the arm 512 to the distal end 516.The flexible instrument 500 can be configured and dimensioned to bendand/or flex when under stress, such as an applied force.

In an aspect, the flexible instrument 500 can include an elongatedportion 514 with a non-flexible surface 518 that extends up to 25% of alength of the elongated portion 514 and the remainder of the length(75%) of the elongated portion 514 can include the flexible pattern 600.

In another aspect not shown, the flexible instrument 500 can include anelongated portion 514 with a flexible pattern 600 near the arm 512 andthe distal end 516, and a non-flexible surface in between the flexiblepattern 600. In a further aspect, the flexible instrument 500 caninclude an elongated portion 514 with a non-flexible surface 518 nearthe arm 512 and the distal end 516, and a flexible pattern 600 inbetween the non-flexible surface 518 areas, as shown in FIGS. 20A-C, forexample.

The flexible pattern of material on the flexible instrument may bevaried in many ways, such as those shown in FIGS. 2A, 2B, 3A, 3B, 4A,and 4B. In these variations, the flexible pattern of flexible instrument500 shown in FIGS. 20A-C may be substituted with flexible pattern 200shown in any one of FIGS. 2A, 2B, 3A, 3B, 4A and 4B. Thus, the flexibleinstrument 500 can include a surface with a flexible pattern 600, inwhich the flexible pattern 600 includes a continuous line of material,as shown in FIGS. 2A, 2B, 3A, 3B, 4A, and 4B. As shown in FIGS. 2A, 2B,3A, 3B, 4A, and 4B, the shaded area is the continuous line of materialforming the flexible pattern 200. The white area is the absence ofmaterial. The continuous line of material can include a plurality ofsegments 202 that interconnect to form rows and columns. A segment 202can include a first end and a second end in which the first end of eachsegment 202 can interconnect with at least one second end of anothersegment 202 of the plurality of segments 202, for example in an adjacentrow or column. In an aspect, a first end of a segment 202 caninterconnect with three different segments to form the continuous lineof material. In a further aspect, a second end of a segment 202 caninterconnect with three different segments to form the flexible pattern200 with a continuous line of material.

In another aspect as shown in FIG. 5A, the segment 202 can fliporientations within the continuous line of material so that in a firstconfiguration the segment 202 forms rows and in an adjacent secondconfiguration the segment 202 forms columns. The flexible pattern 200can also increase in size. For example, as shown in FIG. 5A, theinnermost columns and rows are smaller in size than the outermostcolumns and rows. Accordingly, the stiffness in the interior of theflexible pattern 200 is expected to be lower than a stiffness along theouter edges, e.g., perimeter, of the flexible pattern 200.

Also shown in FIGS. 2A, 2B, and 5A, the flexible pattern 200 can includea continuous line of material that forms corners, which can be used toform smaller or denser patterns. A flexible pattern 200 with corners canbe harder to manufacture. As shown in FIGS. 3A, 3B, 4A, 4B, and 5C, theflexible pattern 200 can comprise curves, arches, and/or curlicues,which can be used to form larger or less dense patterns. A flexiblepattern 200 with curves, arches, and/or curlicues can be easier tomanufacture.

The continuous line of material can be any biocompatible material, suchas a metal, an alloy, a polymer, and combinations thereof, such as ablend of a metal and a polymer. The continuous line of material can havea uniform width. In an aspect, a width of the continuous line ofmaterial can vary. In an aspect, the continuous line of material caninclude straight areas and/or curved areas.

In further variations, the flexible pattern may also be as shown inFIGS. 6-10 and described above. The material cut outs of the flexiblepattern may all be perpendicular to a surface with the flexible pattern,some may be at an acute angle relative to the surface, or the cut outsmay be any combination of orientations as described above. Further, thecut outs may be partially or entirely through a thickness of thestructure, such as an outer wall structure, as described above.

The flexible instrument 500 can be formed by known manufacturingmethods, such as additive layer manufacturing, e.g., three-dimensionalprinting, chemical etching, photo etching, laser cutting, water jetcutting, and traditional machining, etc. Additive layer manufacturingmay be performed in any of the ways described above, for example.

The flexible pattern 600 can transition from a less dense, i.e., fartherapart, pattern near the arm 512 of the elongated portion 514 to adenser, i.e., closer together, pattern at a distal end 516 of theelongated portion 514. The transition of the flexible pattern 600 alonga length of the elongated portion 514 can be equivalent from near thearm 512 to a distal end 16 and vice versa. The transition of theflexible pattern 600 can also be graduated so that there are gradientzones of varying flexibility along a length of the elongated portion 514of the flexible instrument 500.

As shown in FIGS. 12A-12D, the flexible pattern 600, shown as flexiblepattern 200, as noted above, can be the same or different and/or can bepresent or absent across the at least one surface of the flexibleinstrument 500. In an aspect, the flexible pattern 200 can be presentacross the entire surface, as shown in FIG. 12A, or can be present insections (i.e., can be absent in sections) of the at least surface, suchas shown in FIGS. 12B-12D. In another aspect, the flexible pattern 200can be present in a section to form a perimeter 206 of the at least onesurface without being present at an interior of the at least onesurface, as shown FIG. 12C. The flexible pattern 200 can also be presentin an interior 208, without extending to one or more edges, to form acenter of the at least one surface, as shown in FIGS. 12B and 12D.

The flexible pattern 600 can transition from a perimeter to an interiorso that the perimeter is more flexible than the interior and vice versa.For example, the flexible pattern 600 can transition from a less dense,i.e., farther apart, pattern at a perimeter to a denser, i.e., closertogether, pattern at an interior of the at least one surface. As afurther example, the flexible pattern 600 can transition from a denser,i.e., closer together, pattern at a perimeter to a less dense, i.e.,farther apart, pattern at an interior of the at least one surface. Thetransition of the flexible pattern 600 can be equivalent from aperimeter to an interior and vice versa. The transition of the flexiblepattern 600 can be graduated so that there are gradient zones of varyingflexibility across the at least one surface.

The at least one surface can include alternating sections. For example,a first section of the at least one surface can be more rigid. A secondsection can be adjacent to the first section and can be more flexible.The number of alternating rigid and flexible sections can vary. The atleast one surface can be more rigid depending upon variables, such asthe density of the pattern and/or the thickness of the material used toform the pattern. Similarly, the at least one surface can be moreflexible with, for example, a less dense pattern and/or a thinnermaterial used to form the pattern. In another aspect, the at least onesurface can include an alternating section of a first section with aflexible pattern 600 and a second section with a non-flexible surface118.

The at least one surface can have a uniform thickness, such as shown inthe elongated portion 514 in FIG. 20C. In another aspect, the at leastone surface can have a thickness that varies. The thickness can vary bysections. For example, the at least one surface can have a first sectionthat is thin adjacent to a second section that is thick (compared to thefirst section). The thin/thick sections can alternate across the atleast one surface and can affect the flexibility of the at least onesurface. In another aspect, the thickness can vary along a gradient ofthe at least one surface, such as from thick to thin or vice versa. Itis expected that a section of the at least one surface that is thickerthan another section will also be more rigid. Similarly, it is expectedthat a section of the at least one surface that is thinner than anothersection will also be more flexible, as shown in FIGS. 16A-C and FIGS.17A-C, where like reference numerals in the 100 and 200 series refer tolike elements in the 500 and 600 series of numerals, respectively, and162 refers to a surface.

In particular, FIGS. 16A-C illustrate the side view of, for example, asurface 162 having a flexible pattern 200, as shown in FIGS. 17A-C,respectively. FIG. 16A illustrates a surface 162 that is thicker than asurface as shown in FIG. 16B, which is thicker than a surface as shownin FIG. 16C. FIGS. 16A-C and FIGS. 17A-C illustrate that a thin surfacewith a flexible pattern 200 (see, e.g., FIGS. 16C and 17C) can have agreater degree of flexibility as compared to a thicker surface with aflexible pattern 200 (see, e.g., FIGS. 16A and 17A).

In another aspect, flexible instrument 500 may be used in a method ofretraction to create or modify a portal to a surgical site within apatient. Increased flexural properties on customized areas of theinstrument provide a final retracted space for use in access to thesurgical site that is closer to a desired size than would be possiblewithout the flexural properties provided by the flexible regions.

One reason flexible instrument 500 is advantageous is that the inclusionof a flexible pattern surface provides the instrument with increasedversatility, reducing surgical steps requiring both hands of a surgeonand otherwise minimizing a size of incision required for use of theinstrument.

Flexible Rod

In one aspect, the present disclosure is directed to rod 700 including afirst end 712, a second end 716, and a body 714 with a flexible pattern800, wherein the flexible pattern 800 includes a continuous line ofmaterial. The flexibility of a surface can be determined by varioustechniques including determining the stiffness of a surface, i.e., theresistance of a surface to elastic deformation. Stiffness is a measureof the applied force divided by the deflection of the surface. Variablesassociated with the flexible pattern can alter the stiffness of thesurface. By selecting certain variables, a specific stiffness can beachieved in response to a given load. The flexible pattern can provide astiffness to a surface that can be measured, for example, using acompressive load. The stiffness of a surface including a flexiblepattern relative to another surface without the flexible pattern canvary from about 25% to about 100%, for example, from about 35% to about90%, and as a further example from about 50% to about 80%.

As shown in FIGS. 21A-21L, the rod 700 is an elongate member thatextends from a first end 712 to a second end 716. The rod 700 includes abody 714 located between the first end 712 and the second end 716. Eachof the first end 712 and the second end 16 may be independentlyconfigured and dimensioned, such as including a multi-faceted exteriorsurface, to receive a tool, driver, screw, etc. (not shown) to assist auser in manipulating, such as by flexing, the rod 700. The first end 712and the second end 716 of the rod 700 can each independently have ablunt end or a pointed end. In another aspect, the first end 712 and thesecond end 716 can independently include a non-flexible surface, e.g., asurface absent the flexible pattern 800.

The rod 700 can have a body 714 with a surface including a flexiblepattern 800. In an aspect, the flexible pattern 800 can be presentacross the entire surface of the body 714 or can be present in sections,as shown in FIGS. 21B-21L. For example, the body 714 can include asection of the surface of the body 714 with a flexible pattern 800, andcan include a non-flexible surface 718, i.e., a surface of the body 714without a flexible pattern 800. The non-flexible surface 718 of the body714 can provide stability to the rod 700 and can influence the directionof flexibility of the rod 700. For example, as shown in FIG. 21D, therod 700 can bend away from the non-flexible surface 718 of the body 714.

The flexible pattern 800 can extend at least a quarter of a length ofthe body 714. In another aspect, the flexible pattern 800 can extend atleast a half of a length of the body 714, as shown in FIGS. 21E and 21F.In an aspect, the flexible pattern 800 can extend an entire length ofthe body 714, such as from the first end 712 to the second end 716, asshown in FIGS. 21A and 21B. The rod 700 can be configured anddimensioned to bend and/or flex when under stress, such as an appliedforce.

In an aspect, the rod 700 can include a body 714 with a non-flexiblesurface 718 that extends up to 25% of a length of the body 714 and theremainder of the length (75%) of the body 714 can include the flexiblepattern 800, as shown in FIGS. 21G and 21H. The non-flexible surface 718can provide strength when used in a diseased area of a spinal column.The transition in the rod 700 from a non-flexible surface 718 to aflexible pattern 800 can allow for a “softer” transition frominstrumented levels to uninstrumented levels to reduce stress.

In another aspect, the rod 700 can include a body 714 with a flexiblepattern 800 near the first end 712 and the second end 716, and anon-flexible surface 718 in between the flexible pattern 800, as shownin FIGS. 21I and 21J. In a further aspect, the rod 700 can include abody 714 with a non-flexible surface 718 near the first end 712 and thesecond end 716, and a flexible pattern 800 in between the non-flexiblesurface 718 areas, as shown in FIGS. 21K and 21L.

As shown in FIGS. 21B-21D, the flexible pattern 800 can be present onthe body 714 with a non-flexible surface 718 that separates the flexiblepattern 800 as it continues around the body 714. In another aspect, theflexible pattern 800 can be present on the entire body 714 without anon-flexible surface 718.

The rod 700 can include a surface with a flexible pattern 800, in whichthe flexible pattern 800 includes a continuous line of material, asshown in FIGS. 2A, 2B, 3A, 3B, 4A, and 4B. In these variations, theflexible pattern of rod 700 shown in FIGS. 21A-L may be substituted withflexible pattern 200 shown in any one of FIGS. 2A, 2B, 3A, 3B, 4A and4B. As shown in FIGS. 2A, 2B, 3A, 3B, 4A, and 4B, the shaded area is thecontinuous line of material forming the flexible pattern 200. The whitearea is the absence of material. The continuous line of material caninclude a plurality of segments 202 that interconnect to form rows andcolumns. A segment 202 can include a first end and a second end in whichthe first end of each segment 202 can interconnect with at least onesecond end of another segment 202 of the plurality of segments 202, forexample in an adjacent row or column. In an aspect, a first end of asegment 202 can interconnect with three different segments to form thecontinuous line of material. In a further aspect, a second end of asegment 202 can interconnect with three different segments to form theflexible pattern 200 with a continuous line of material.

In another aspect as shown in FIG. 5A, the segment 202 can fliporientations within the continuous line of material so that in a firstconfiguration the segment 202 forms rows and in an adjacent secondconfiguration the segment 202 forms columns. The flexible pattern canalso increase in size. For example, as shown in FIG. 5A, the innermostcolumns and rows are smaller in size than the outermost columns androws. Accordingly, the stiffness in the interior of the flexible pattern200 is expected to be lower than a stiffness along the outer edges,e.g., perimeter, of the flexible pattern 200.

As shown in FIGS. 2A, 2B, and 5A, the flexible pattern 200 can include acontinuous line of material that forms corners, which can be used toform smaller or denser patterns. A flexible pattern 200 with corners canbe harder to manufacture. As shown in FIGS. 3A, 3B, 4A, 4B, and 5C, theflexible pattern 200 can comprise curves, arches, and/or curlicues,which can be used to form larger or less dense patterns. A flexiblepattern 200 with curves, arches, and/or curlicues can be easier tomanufacture.

The continuous line of material can be any biocompatible material, suchas a metal, an alloy, a polymer, and combinations thereof, such as ablend of a metal and a polymer. The continuous line of material can havea uniform width. In an aspect, a width of the continuous line ofmaterial can vary. In an aspect, the continuous line of material caninclude straight areas and/or curved areas.

In further variations, the flexible pattern may also be as shown inFIGS. 6-10 and described above. The material cut outs of the flexiblepattern may all be perpendicular to a surface with the flexible pattern,some may be at an acute angle relative to the surface, or the cut outsmay be any combination of orientations as described above. Further, thecut outs may be partially or entirely through a thickness of thestructure, such as an outer wall structure, as described above.

The rod 700 can be formed by known manufacturing methods, such asadditive layer manufacturing, e.g., three-dimensional printing, chemicaletching, photo etching, laser cutting, water jet cutting, andtraditional machining, etc. Additive layer manufacturing may beperformed in any of the ways described above, for example.

The flexible pattern 800 can transition from a less dense, i.e., fartherapart, pattern at a first end of the body 714 to a denser, i.e., closertogether, pattern at a second end of the body 714. The transition of theflexible pattern 800 along a length of the body 714 can be equivalentfrom a first end to a second end of the body 714 and vice versa. Thetransition of the flexible pattern 800 can also be graduated so thatthere are gradient zones of varying flexibility along a length of thebody 714 of the rod 700.

In another aspect, the rod 700 may be used in a method of spinalalignment correction as an element to interconnect bone anchors onadjacent vertebrae. During adjustment of the rod during a procedure, therod may bend to render adjustment simpler. With the rod, less force isrequired to adjust the rod relative to a rod without flexible regions.

One advantage of the flexible rod is its versatility during use insurgery. In particular, adjustment of the rod position to accommodateanchor placement is less difficult in view of the flexible regions onthe rod.

Corpectomy

In one aspect, the present disclosure is directed an adjustable cagedevice 900 comprising at least one surface 915 with a flexible pattern1000, wherein the flexible pattern 1000 includes a continuous line ofmaterial. The adjustable cage device 900 can be a foldable cage, such asshown in FIGS. 22A-22C or an expandable cage, such as shown in FIGS.23A-23D. The flexibility of a surface 915 can be determined by varioustechniques including determining the stiffness of a surface, i.e., theresistance of a surface to elastic deformation. Stiffness is a measureof the applied force divided by the deflection of the surface. Variablesassociated with the flexible pattern can alter the stiffness of thesurface. By selecting certain variables, a specific stiffness can beachieved in response to a given load. The flexible pattern can provide astiffness to a surface that can be measured, for example, using acompressive load. The stiffness of a surface including a flexiblepattern relative to another surface without the flexible pattern canvary from about 25% to about 100%, for example, from about 35% to about90%, and as a further example from about 50% to about 80%.

FIGS. 22A-22B illustrate an adjustable cage device 900, such as afoldable cage, comprising at least one surface 915 with a flexiblepattern 1000, wherein the flexible pattern 1000 includes a continuousline of material. The adjustable cage 900 device can be a foldable orrollable cage. In an aspect, the adjustable cage device 900 can includeat least one endplate 920, for example two endplates.

The at least one endplate 920 can include an exterior surface that canbe smooth (not shown) or can include a plurality of projections 922, asshown in FIGS. 22A-C. A smooth surface can be even and regular, i.e., itdoes not include any projections 922 from the at least one surface. Theplurality of projections 922 can be adapted to engage a vertebra or anytissue. The plurality of projections 922 can be arranged in rows and/orcolumns spreading along the endplate 920. The plurality of projections922 can inhibit movement of the adjustable cage device 900 whenpositioned in place.

In an aspect, the adjustable cage device 900 has an endplate 920including at least one smooth surface. In another aspect, the adjustablecage device 900 has an endplate 920 including at least one smoothsurface with a flexible pattern 1000. In another aspect, the adjustablecage device 900 has an endplate 920 including a least one surface with aflexible pattern 1000 and a plurality of projections 922, as shown inFIG. 22D. In another aspect, the adjustable cage device 900 has anendplate 920 including at least one surface with a plurality ofprojections 922.

The endplate 920 can include an interior surface that includes a channel930 that extends along an inner edge of the endplate 920. For example,as shown in FIG. 22A, the channel 930 can extend along the circumferenceof the inner edge. The channel 930 can be configured and dimensioned toreceive an edge 935 a, 935 b of the at least one surface including aflexible pattern 1000. The edge 935 of the at least one surfaceincluding a flexible pattern 1000 can fit within the channel. Theflexible pattern 1000 can provide flexibility to the surface so that itbends along the circumference of the endplate 920.

The endplate 920 can vary in dimension. In an aspect, the endplate 920can be any shape, such as a circle, a square, a triangle, or any otherpolygon. In another aspect, the endplate 920 can be any size. Theadjustable cage device 900 can range from about 10 mm to about 60 mm,for example from about 12 mm to about 20 mm. The adjustable cage device900 can also be a rectangular size ranging from about 11 mm×11 mm toabout 45 mm×50 mm, such as from about 12 mm×14 mm to about 17 mm×20 mmDuring an operation, a user can select from various sized endplates 920and from various surfaces including the flexible pattern 1000 to make asuitable adjustable cage device 900 for the patient.

As shown in FIG. 22B, the adjustable cage device 900 can include anopening 940. The opening 940 can be configured and dimensioned so that auser can insert a bone support matrix into the adjustable cage device900. As used herein, a “bone support matrix” is a material thatfacilitates osteogensis. Suitable bone support matrices can beresorbable or nonresorbble and osteoconductive or osteoinductive.Non-limiting examples of suitable bone support matrices includesynthetic materials, bone morphogenic proteins (BMPs), and heterologous,homologous, or autologous bone and derivatives thereof. The bone supportmatrix may be radiolucent on x-rays.

FIGS. 23A-23D illustrate an adjustable cage device 900 according toanother aspect of the disclosure. The adjustable cage device cage 900can be a corpectomy cage and can be designed for supporting adjacentvertebra. A user may, in real time, independently adjust the height ofthe adjustable cage device 900. During operation, the user can adjustthe height of the adjustable cage device 900 by moving a housing 950relative to a support member 960 to accommodate adjustable cage device900 in a variable space located between adjacent vertebrae. Afterplacing adjustable cage device 900 in such a space, a top surface 970with a flexible pattern 1000 (as shown in FIGS. 23A-23B) and/or ahousing 950 with a flexible pattern 1000 can flex to mimic or closelymatch the surface of the adjacent vertebrae. As will be appreciated byone of ordinary skill in the art the ability to mimic or closely matchthe surface of the adjacent vertebra can improve the stability of thespine by providing a better fit between adjacent vertebrae and therebyimprove osteogenesis.

As shown in FIGS. 23A, 23C, and 23D, the adjustable cage device 900 caninclude a housing 950, a support member 960, and a top surface 970,wherein at least one of the housing 950 and the top surface 970 caninclude a flexible pattern 1000. In aspect, one of ordinary skill in theart could include additional support members (not shown) to theadjustable cage device 900, wherein the additional support members couldbe used to further increase the height of the adjustable cage device 900and/or provide angled top surfaces 970 (not shown) in multiple planes.

In an aspect, an initial height of the adjustable cage device 900 canrange from about 12 mm to about 130 mm. One of ordinary skill in the artwill appreciate that the initial height of an adjustable cage device 900can be based in part upon the initial footprint of the adjustable cagedevice 900. For example, an adjustable cage device 900 with a smallerfootprint will likely have a smaller initial height. The initial heightof the adjustable cage device 900 can be increased by, for example, anadditional 4 mm One of ordinary skill in the art will understand thatthe height of the adjustable cage device 900 can be increased in anyincrement from 0 mm and 16 mm, such as for example from about 0.5 mm toabout 15.5 mm, from about 1.0 mm to about 14.0 mm, and as anotherexample from about 2.0 mm to about 13.0 mm.

In an aspect, an angle of the top surface 970 of the adjustable cagedevice 900 can also be adjusted. In an aspect, an initial angle of thetop surface 970 of the adjustable cage device 900 can be 0° with respectto an x-axis, as shown in FIGS. 23A-23D. However, this angle can beadjusted to better align the endplate 940 with an adjacent vertebra tomore accurately align the adjustable cage device 900 with the adjacentvertebra. In an aspect, the angle can be adjusted to any increment from0° to about 45°, including any angle in between, such as 15°, 20°, and30°. One of ordinary skill in the art would be able to adjust the angleof the top surface 970.

The adjustable cage device 900 can be filled with a bone support matrix.

The housing 950 can include an elongate body and defining a longitudinalpassage (not shown). The longitudinal passage can be dimensioned andconfigured to receive at least a portion of the support member 960. Forexample, a wall of the longitudinal passage can include a helical threaddimensioned and configured to engage with an external helical threadpresent on the support member 960.

The adjustable cage device 900 can include at least one surface that caninclude a flexible pattern 1000, wherein the flexible pattern 1000includes a continuous line of material. As shown in FIGS. 22A and 22B,the at least one surface 915 can include the flexible pattern 1000.Additionally, FIG. 22C illustrates an endplate 920 of the adjustablecage device 900 having a surface including a flexible pattern 1000.FIGS. 23A-23D illustrate an adjustable cage device 900 with a housing950 and a top surface 970, each independently, with a flexible pattern1000.

The flexible pattern 1000 can be present on an entire surface, as shownin FIG. 22A. In another aspect, the flexible pattern 200 can be presenton a portion of the surface, as shown in FIGS. 22C, and 23A-23D. Forexample, the flexible pattern 1000 can be present in vertical stripswith a non-flexible surface in between the strips; horizontal stripswith a non-flexible surface in between the strips; an inner area with aperimeter of non-flexible surface (for example, as shown in the topsurface 970 of FIG. 23B); and a perimeter with an inner area of anon-flexible surface. Any and all variations of the flexible pattern1000 on a surface are contemplated.

The flexible pattern of material on the adjustable cage device may bevaried in many ways, such as those shown in FIGS. 2A, 2B, 3A, 3B, 4A,and 4B. In these variations, the flexible pattern of adjustable cagedevice 900 shown in FIGS. 22A-C and 23A-D may be substituted withflexible pattern 200 shown in any one of FIGS. 2A, 2B, 3A, 3B, 4A and4B. As shown in FIGS. 2A, 2B, 3A, 3B, 4A, and 4B, the flexible pattern200 can include a continuous line of material. As shown in FIGS. 2A, 2B,3A, 3B, 4A, and 4B, the shaded area is the continuous line of materialforming the flexible pattern 200. The white area is the absence ofmaterial. The flexible pattern 200 can include a plurality of segments202 that interconnect to form rows and columns. A segment 202 caninclude a first end and a second end in which the first end of eachsegment 200 can interconnect with at least one second end of anothersegment of the plurality of segments, for example in an adjacent row orcolumn. In an aspect, a first end of a segment 202 can interconnect withthree different segments to form the flexible pattern 200 with acontinuous line of material. In a further aspect, a second end of asegment 202 can interconnect with three different segments to form theflexible pattern 200 with a continuous line of material.

In another aspect as shown in FIG. 5A, the segment 202 can fliporientations within the continuous line of material so that in a firstconfiguration the segment forms rows and in an adjacent secondconfiguration the segment forms columns. The flexible pattern can alsoincrease in size. For example, as shown in FIG. 5A, the innermostcolumns and rows are smaller in size than the outermost columns androws. Accordingly, the stiffness in the interior of the flexible pattern200 is expected to be lower than a stiffness along the outer edges,e.g., perimeter, of the flexible pattern 200.

In another aspect as shown in FIG. 5C, the flexible pattern 200 mayinclude a plurality of segments 202 that interconnect to mimic a patternof cortical bone. The segments 202 switch back and forth in an archingpattern and/or curlicue pattern. The stiffness in the interior of theflexible pattern 200 is expected to be higher than a stiffness along theouter edges, e.g., perimeter, of the flexible pattern 200. The flexiblepattern 200 illustrated in FIG. 5C can be a single continuous radiusacross an entire or a portion of a surface. In another aspect, theflexible pattern 200 illustrated in FIG. 5C can be multiple separatespheres across an entire or a portion of a surface.

As shown in FIGS. 2A, 2B, and 5A, the flexible pattern 200 can include acontinuous line of material that forms corners, which can be used toform smaller or denser patterns. A flexible pattern 200 with corners canbe harder to manufacture. As shown in FIGS. 3A, 3B, 4A, 4B, and 5C, theflexible pattern 200 can comprise curves, arches, and/or curlicues,which can be used to form larger or less dense patterns. A flexiblepattern 200 with curves, arches, and/or curlicues can be easier tomanufacture.

The continuous line of material can be any biocompatible material, suchas a metal, an alloy, a polymer, and combinations thereof, such as ablend of a metal and a polymer. For example, the continuous line ofmaterial may be made of polyetheretherketone (PEEK), titanium, stainlesssteel, cobalt chrome, polymeric materials, a combination thereof, or anyother suitable material. The continuous line of material can have auniform width. In an aspect, a width of the continuous line of materialcan vary. In an aspect, the continuous line of material can includestraight areas and/or curved areas.

In further variations, the flexible pattern may also be as shown inFIGS. 6-10 and described above. The material cut outs of the flexiblepattern may all be perpendicular to a surface with the flexible pattern,some may be at an acute angle relative to the surface, or the cut outsmay be any combination of orientations as described above. Further, thecut outs may be partially or entirely through a thickness of thestructure, such as an outer wall structure, as described above.

The at least one surface including a flexible pattern 1000 can be formedby known manufacturing methods, such as additive layer manufacturing,e.g., three-dimensional printing, chemical etching, photo etching, lasercutting, water jet cutting, and traditional machining, etc. Additivelayer manufacturing may be performed in any of the ways described above,for example.

The flexible pattern 1000 can flex under application of a force. In anaspect, a first area of the flexible pattern 1000 can move in adirection relative to a second area of the flexible pattern 1000 underan applied force.

Each surface of the adjustable cage device 900 can be independent fromany other surface of the adjustable cage device 900 in terms ofvariables, such as degree of flexibility, degree of rigidity, density ofthe flexible pattern 1000, form of the flexible pattern 1000, thicknessof the surface including the flexible pattern 1000, and etc. One ofthese variables may impact another variable. For example, a thickhousing 950 with a flexible pattern 1000 can have a higher degree ofrigidity as compared to a thin top plate 970 with a flexible pattern1000 within the same adjustable cage device 900.

In FIGS. 16A-C and 17A-C, like reference numerals in the 100 and 200series refer to like elements in the 900 and 1000 series of numerals,respectively, and 162 refers to a surface. FIGS. 16A-C illustrate theside view of, for example, a surface 162 having a flexible pattern 200,as shown in FIGS. 17A-C, respectively. FIG. 16A illustrates a surface162 that is thicker than a surface as shown in FIG. 16B, which isthicker than a surface as shown in FIG. 16C. FIGS. 16A-C and FIGS. 17A-Cillustrate that a thin surface with a flexible pattern 200 (see, e.g.,FIGS. 16C and 17C) can have a greater degree of flexibility as comparedto a thicker surface with a flexible pattern 200 (see, e.g., FIGS. 16Aand 17A).

As another example, of how one variable of the flexible pattern 1000 caneffect another variable of the flexible pattern 1000, a housing 950, asshown in FIGS. 23A-23B, can have a dense flexible pattern 200 includinga curved line as shown in FIG. 3B, and a top surface 970 can have a lessdense flexible pattern 200 comprising squared lines as shown in FIG. 2B.It is appreciated that each surface with a flexible pattern 1000 of anadjustable cage device 900 can be designed to meet the requirements forits particular use.

As shown in FIGS. 12A-12D, the flexible pattern 200, in place offlexible pattern 1000, can be the same or different and/or can bepresent or absent across the at least one surface of the interbody 100.In an aspect, the flexible pattern 200 can be present across the entiresurface, as shown in FIG. 12A, or can be present in sections (i.e., canbe absent in sections) of the at least surface, such as shown in FIGS.12B-12D. In another aspect, the flexible pattern 200 can be present in asection to form a perimeter 206 of the at least one surface withoutbeing present at an interior of the at least one surface, as shown FIG.12C. The flexible pattern 200 can also be present in an interior 208,without extending to one or more edges, to form a center of the at leastone surface, as shown in FIGS. 12B and 12D.

The flexible pattern 200 can transition from a perimeter to an interiorso that the perimeter is more flexible than the interior and vice versa.For example, the flexible pattern 200 can transition from a less dense,i.e., farther apart, pattern at a perimeter to a denser, i.e., closertogether, pattern at an interior of the at least one surface. As afurther example, the flexible pattern 200 can transition from a denser,i.e., closer together, pattern at a perimeter to a less dense, i.e.,farther apart, pattern at an interior of the at least one surface. Thetransition of the flexible pattern 200 can be equivalent from aperimeter to an interior and vice versa. The transition of the flexiblepattern 200 can be graduated so that there are gradient zones of varyingflexibility across the at least one surface.

The at least one surface can include alternating sections. For example,a first section of the at least one surface can be more rigid. A secondsection can be adjacent to the first section and can be more flexible.The number of alternating rigid and flexible sections can vary. The atleast one surface can be more rigid depending upon variables, such asthe density of the pattern and/or the thickness of the material used toform the pattern. Similarly, the at least one surface can be moreflexible with, for example, a less dense pattern and/or a thinnermaterial used to form the pattern. In another aspect, the at least onesurface can include an alternating section of a first section with aflexible pattern 200 and a second section without a flexible pattern200.

The at least one surface can have a uniform thickness. In anotheraspect, the at least one surface can have a thickness that varies. Thethickness can vary by sections. For example, the at least one surfacecan have a first section that is thin adjacent to a second section thatis thick (compared to the first section). The thin/thick sections canalternate across the at least one surface and can affect the flexibilityof the at least one surface. In another aspect, the thickness can varyalong a gradient of the at least one surface, such as from thick to thinor vice versa. It is expected that a section of the at least one surfacethat is thicker than another section will also be more rigid. Similarly,it is expected that a section of the at least one surface that isthinner than another section will also be more flexible, as shown inFIGS. 16A-C and FIGS. 17A-C.

In another aspect, the adjustable cage device 900 is used in a method ofperforming a corpectomy.

The adjustable cage device 900 is advantageous in that the flexibleregions on the device are adaptable to natural and varying curvature anddimensions of a spine of a patient. For example, upper and lowersurfaces of the device adapt to conform to a bone surface of a vertebraopposite a device surface when the device is positioned within thespine. This reduces or eliminates problems associated with gaps betweena cage device and adjacent vertebral bodies.

Other Implant Structures

In one aspect, the present disclosure relates to a flexible interbody1100 as shown in FIGS. 24-26. Interbody 110 includes a ring shaped body1102 surrounding an opening 1130. An inner side surface 1114 defines aboundary of opening 1130 while outer side surface 1116 defines an outerperimeter of body 1102. Top surface 1112 and an opposite bottom surface(not shown) are symmetrical about a plane passing centrally therebetweenand perpendicular to outer side surface 1116. Both top surface 1112include protrusions 1122 thereon in the form of teeth angled in a singledirection. An inner portion of top surface 1112 remote from outer sidesurface 1116 and abutting inner side surface 1114 includes a flexiblepattern 1200. As shown, flexible pattern 1200 is the same as that shownin FIGS. 3A and 3B. A segment 1202 is illustrative of the aforementionedpattern. Flexible pattern 1200 extends from top surface throughout innerside surface 1114, as shown in FIG. 26, and through a portion of thebottom surface in a manner similar to top surface 1112. The performanceof implant 1100 with flexible pattern 1200 may be as described above forflexible pattern 200. In variants, pattern 1200 shown may be substitutedwith another pattern such as that shown in FIGS. 1C, 2A, 2B, 4A-4B,5A-5D and 6-10.

In another aspect, the present disclosure relates to a plate 1300 asillustrated in FIGS. 27 and 28. Plate 1300 is symmetrical about one axisand includes a body 1302 with a first portion 1310, a second portion1320 and a third portion 1330, each extending in a linear manner from acentral area 1304 surrounding an opening 1318. First portion 1310includes three openings 1316, 1317, 1318, each having a countersink.Second and third portions 1320, 1330 each include a slot 1326, 1336,respectively, therein. Each slot includes a counterbore as shown.Flexible pattern 1400A-D is located over various areas on plate 1300between openings, slots or openings and slots. In particular, flexiblepattern 1400A is located between openings 1316 and 1317 and flexiblepattern 1400B is located between openings 1317 and 1318. Similarly,flexible patterns 1400C and 1400D are located between opening 1318 andslots 1326 and 1336, respectively. In this manner, flexible pattern1400B-D surrounds opening 1318 on three sides in central area 1304.Here, a segment 1402 illustrates that flexible pattern 1400 is the sameas that shown in FIGS. 3A-B. In variants, the flexible pattern may bemay be substituted with another pattern such as that shown in FIGS. 1C,2A, 2B, 4A-4B, 5A-5D and 6-10. Through the inclusion of flexibleregions, the plate is more versatile in its application on a targetanatomical surface. For example, it may deform to match contours of asurface thereby minimizing gaps between the plate and the surface towhich it is applied.

In yet another aspect, the present disclosure relates to a plate 1500shown in FIGS. 29 and 30. Plate 1500 includes body 1502 with peripheralopenings 1512, 1514, 1516, 1518 located at respective corners of theplate and additional openings 1522, 1524 located slightly interior andcentral to opening pairs 1512, 1516 and 1514, 1518, respectively. In acentral region of plate 1500 is flexible pattern 1600, the pattern alsoshown in FIGS. 3A-B. In variants, the flexible pattern may be may besubstituted with another pattern such as that shown in FIGS. 1C, 2A, 2B,4A-4B, 5A-5D and 6-10.

In another aspect, the present disclosure relates to a knee implantsystem 1700 that includes a femoral component 1710 and a tibialcomponent 1750. Femoral component 1710 includes a condyle portion 1712,a contact portion 1714 and an anterior portion 1716. In thisarrangement, each angulation on an interior surface of femoral component1710 includes a surface with a flexible pattern thereon. Specifically,and as shown in FIG. 31, flexible pattern 1800A-D is formed atrespective angulations on the interior surface of femoral component1710. The inclusion of flexible pattern 1800A-D in the manner describedis advantageous in that the femoral component may change shape duringimplantation to accommodate any irregularities in the surface of theresected femur to which the implant is to be attached. This in turnreduces or otherwise eliminates the need to perform resurfacing prior tofinal positioning of the implant. The flexible pattern on the implantmay be one or more of those shown in FIGS. 1C, 2A, 2B, 3A-B, 4A-4B,5A-5D and 6-10, for example.

As with other aspects of the disclosure described above, the cut outs ofthe flexible pattern of each implant may all be perpendicular to asurface with the flexible pattern, some may be at an acute anglerelative to the surface, or the cut outs may be any combination oforientations as described above. Further, the cut outs may be partiallyor entirely through a thickness of the structure, such as an outer wallstructure, as described above. Further, the implants may be formed byknown manufacturing methods, such as additive layer manufacturing, e.g.,three-dimensional printing, chemical etching, photo etching, lasercutting, water jet cutting, and traditional machining, etc. Additivelayer manufacturing may be performed in any of the ways described above,for example.

In another aspect, the present disclosure relates to an interbodyimplant 1900 shown in FIGS. 32-35. Interbody 1900 includes body 1902with a first surface 1916, second surface 1918, top surface 1912 andbottom surface 1914. Extending through interbody 1900 at angles withrespect to each other are openings 1922, 1924. Each opening 1922, 1924defines an axial path for a fastener or other anchoring element. To forma complete enclosure around each opening while also preserving a fulldiameter pathway through the interbody, each opening is partiallydefined by an opening enclosure element in the shape of an arch and muchnarrower than the remainder of body 1902. In particular, opening 1922 ispartially defined by first opening enclosure 1913 while opening 1924 ispartially defined by second opening enclosure 1915.

Each opening includes unique flexible features to allow engagement withan element inserted therein. Within opening 1922 is a continuous stripof material 1950 over a portion of opening perimeter, as shown in FIGS.32, 34 and 35. Two separate gaps 1962, 1964 define a shape of continuousstrip 1950, while a portion of continuous strip 1950 protrudes 1952relative to the rest. As shown in the depicted embodiment, gap 1962 isC-shaped and gap 1964 is T shaped. In alternative arrangements, thegeometry of gaps 1962, 1964 may vary from that shown. Gaps 1962, 1964may be between 0.003 to 0.200 inches in width. In one preferredarrangement, gaps 1962, 1964 are between 0.006 and 0.080 inches inwidth. When an object is placed through opening 1922, strip 1950, havingelastic properties, deforms to allow the object to pass and then returnsto its original shape upon passage of the object. In this manner, theobject may be secured in place within the opening. Turning to opening1924, a surface defining such opening includes a pair of hooks 1972,1974, best shown in FIG. 34. Each hook is freestanding within an openingin an inner surface defining opening 1924 and includes an end tip in theform of a hook that extends inward into opening 1924. In this manner,the tips of each hook 1972, 1974 protrude relative to the cylindricalsurface that defines opening 1924. Each hook 1972, 1974 has a degree offlexibility permitting bending during insertion of an objecttherethrough so that upon passage of the object, the applicable hookreturns to its undeformed shape, thereby providing a secure connectionbetween the interbody and the inserted object. Interbody implant 1900may be attached to or formed with a plate (not shown) or anotherstandalone device. Thus, in one non-limiting example, fasteners may beused to secure an interbody 1900 that includes a plate to a bone.Specifically, fasteners may be inserted through the openings in theinterbody and into the bone, locking to both the interbody and the bonein the process. Because the plate is part of the interbody, the plate isalso locked in place.

In any one of the above embodiments, a single structure with flexiblesurface regions may have two or more types of flexible patterns. Anycombination of patterns described or otherwise contemplated herein maybe included in these combinations.

In another aspect, the present disclosure relates to a flexible surfacethat includes a flexible pattern. The material of the surface may be anycontemplated for use in a surgical procedure. In one embodiment, theflexible pattern is as shown in FIGS. 2A-2B and described above. Inother embodiments, the flexible pattern is one of the patterns shown inFIGS. 3A-3B, 4A-4B, 5A-5B, 5C-5D and 6-10 and described above. Theflexible surface may also include other patterns as contemplated by thepresent disclosure. In other embodiments, the flexible pattern mayinclude any combination of the aforementioned patterns.

Although the disclosure herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent disclosure. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present disclosure as defined by the appended claims.

1-99. (canceled)
 100. An intervertebral implant comprising: an upperendplate surface and a lower endplate surface opposite the upperendplate surface; and a first portion on one of the upper endplatesurface and the lower endplate surface, the first portion including afirst flexible surface with a plurality of segments that define aplurality of slits, the plurality of slits including a first slit and asecond slit, the first slit crossing the second slit between first andsecond ends of the second slit, wherein the first flexible surface has asurface contour that changes as a function of force borne by the firstflexible surface.
 101. The implant of claim 100, wherein the firstflexible surface is flexible in a direction transverse to a plane thatis approximately aligned with the first flexible surface.
 102. Theimplant of claim 100, wherein the first flexible surface is translatablein a direction orthogonal to a plane that passes through the firstflexible surface at a second location when force is applied at thesecond location.
 103. The implant of claim 100, wherein the plurality ofsegments include a first segment, a second segment, a third segment anda fourth segment, each segment extending radially from a first locationand each segment being oriented differently relative to the firstlocation than the other segments.
 104. The implant of claim 103, whereinthe plurality of segments are positioned such that a first axis passingthrough a first midpoint of a first length of the first segment and asecond midpoint of a second length of the second segment is orthogonalto a second axis passing through the first midpoint of the first segmentand a third midpoint of a third length of the third segment.
 105. Theimplant of claim 100, wherein the plurality of segments interconnect toform rows and columns.
 106. The implant of claim 103, wherein each ofthe first, second, third and fourth segments have the same shape. 107.The implant of claim 100, further comprising a second flexible surfacewith a second plurality of slits, the second flexible surface beingdifferent from the first flexible surface.
 108. The implant of claim103, wherein the first segment includes a first portion, a secondportion and a third portion, the first portion being linear and orientedin a first direction, the second portion being linear and oriented in asecond direction different from the first direction, and the thirdportion being linear and oriented in a third direction different fromthe second direction.
 109. The implant of claim 100, further comprisingat least one non-flexible surface.
 110. The implant of claim 100,wherein each of the plurality of slits extend entirely through the firstportion of the implant.
 111. The implant of claim 110, wherein theplurality of slits include at least two slits that are oriented atdifferent angles relative to the first flexible surface.
 112. A methodof using an implant comprising: providing the implant, the implantincluding a first portion with a flexible surface; inserting the implantinto a final operative location within a patient, and deforming thefirst portion of the implant based on force applied to the flexiblesurface, the force causing a contour of the flexible surface to change.113. The method of claim 112, wherein deforming the first portion of theimplant occurs while the implant is disposed in the final operativelocation.
 114. The method of claim 113, wherein the final operativelocation is an intervertebral space and deforming the first portion ofthe implant occurs in a spinal column of the patient, the deformationresulting from force applied to the flexible surface by a vertebralbody.
 115. The method of claim 112, wherein the implant is a fixationmember and deforming the first portion involves bending a shaft of thefixation member.
 116. The method of claim 112, wherein deforming occursonly in the first portion and a second portion of the implant retainsits shape before and after being subject to force.
 117. A method ofmanufacturing an implant comprising: conducting an additivemanufacturing technique in a layer by layer fashion to form a completeimplant including formation of one or more layers with a plurality ofslits therein, the plurality of slits defining a pattern such that thecomplete implant includes a first portion having a first surface withthe pattern, the first portion being more flexible than a second portionof the complete implant, the second portion being devoid of slits. 118.The method of claim 117, wherein the formation of one or more layersinvolves forming the plurality of slits to define a plurality ofsegments, the plurality of segments including a first segment, a secondsegment, a third segment and a fourth segment, each segment having thesame shape and extending radially from a first location and each segmentbeing oriented differently relative to the first location than the othersegments.
 119. The method of claim 118, wherein the first segmentincludes a first portion, a second portion and a third portion, thefirst portion being linear and oriented in a first direction, the secondportion being linear and oriented in a second direction different fromthe first direction, and the third portion being linear and oriented ina third direction different from the second direction.
 120. The methodof claim 117, wherein conducting the additive manufacturing techniqueforms the first portion of the complete implant such that the firstsurface has a surface contour that changes as a function of forceapplied to the first surface.
 121. The method of claim 117, whereinconducting the additive manufacturing technique forms one of a fixationmember, a rod, a plate, a spinal interbody, and an adjustable cagedevice.